Efficacy of Probiotics and Nutrients in Functional Gastrointestinal Disorders: A Preliminary Clinical Trial
Abstract
The purpose of this study was to evaluate the efficacy and safety of commonly used probiotics and nutrients available for functional gastrointestinal disorders (FGID). Five different combinations of probiotics and nutrients, or placebo, were taken daily over 12 weeks. In this randomized controlled clinical trial, men and women 21 to 72 years of age with FGID symptoms of indigestion, bloating, and abdominal discomfort were assigned to one of six groups, 12 patients per group. Gastrointestinal Quality of Life Index (GIQLI) and visual analogue scale (VAS) for GI symptoms, SF-36, lactulose and mannitol test (LMT), and urine indican levels were evaluated. GIQLI, VAS scores, and LMT did not change significantly (P > 0.05). There were clinically notable improvements in two of the combination formulations. While the nonsignificant improvements in GI symptoms could suggest that combination probiotics and nutrients may be beneficial in conditions such as FGID, no conclusive evidence was found in this pilot trial. Further investigations to explore the findings are discussed.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Specific probiotics may help reduce constipation in some patients with IBS, with low grade of evidence.
“Specific probiotics may help reduce constipation in some patients with IBS Low [155-156,183,185]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [183]
Probiotics tested to date do not reduce diarrhea in patients with IBS, with very low grade of evidence.
“Probiotics tested to date do not reduce diarrhea in patients with IBS Very low [174,179,181-183,185,187]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [183]
Cites
Dermyshi, E., Wang, Y., Yan, C., Hong, W., Qiu, G., Gong, X., & Zhang, T. (2017) · Neonatology · doi:10.1159/000454668 · Cited by 24,577 · see citing works
Changes of Intestinal Functions in Liver Cirrhosis
Fukui, H., & Wiest, R. (2016) · Inflammatory Intestinal Diseases · doi:10.1159/000444436 · Cited by 6,820 · see citing works
Functional bowel disorders and functional abdominal pain
Thompson, W. G., Longstreth, G. F., Drossman, D. A., Heaton, K. W., Irvine, E. J., & Müller-Lissner, S. A. (1999) · Gut · doi:10.1136/gut.45.2008.ii43 · Cited by 2,440 · see citing works
Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial
Kalliomäki, M. A., Salminen, S., Arvilommi, H. S., Kero, P. O., Koskinen, P. J., & Isolauri, E. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04259-8 · Cited by 2,434 · see citing works
The functional gastrointestinal disorders and the Rome III process
Drossman, D. A. (2006) · Gastroenterology · doi:10.1053/j.gastro.2006.03.008 · Cited by 2,416 · see citing works
Drossman, D. A., Li, Z., Andruzzi, E., Temple, R. D., Talley, N. J., Grant Thompson, W., Whitehead, W. E., Janssens, J., Funch-Jensen, P., Corazziari, E., et al. (1993) · Digestive Diseases and Sciences · doi:10.1007/bf01303162 · Cited by 2,198 · see citing works
O’Mahony, L., McCarthy, J., Kelly, P., Hurley, G., Luo, F., Chen, K., O’Sullivan, G. C., Kiely, B., Collins, J. K., Shanahan, F., et al. (2005) · Gastroenterology · doi:10.1053/j.gastro.2004.11.050 · Cited by 1,448 · see citing works
Gastrointestinal Quality of Life Index: Development, validation and application of a new instrument
Eypasch, E. P., Williams, J. I., Wood-Dauphinée, S., Ure, B. M., Schmulling, C., Neugebauer, E. A. M., & Troidl, H. (1995) · British journal of surgery · doi:10.1002/bjs.1800820229 · Cited by 1,299 · see citing works
Kruis, W., Frič, P., Pokrotnieks, J., Lukáš, M., Fixa, B., Kaščák, M., Kamm, M. A., Weismueller, J., Beglinger, C., Stolte, M., et al. (2004) · Gut · doi:10.1136/gut.2003.037747 · Cited by 1,285 · see citing works
Kailasapathy, K., & Chin, J. J.-C. (2000) · Immunology and Cell Biology · doi:10.1046/j.1440-1711.2000.00886.x · Cited by 778 · see citing works
Taxonomy and important features of probiotic microorganisms in food and nutrition
Holzapfel, W. H., Haberer, P., Geisen, R. M., Björkroth, J. K., & Schillinger, U. (2001) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/73.2.365s · Cited by 763 · see citing works
Tlaskalová‐Hogenová, H., Štëpánková, R., Hudcovic, T., Tučková, L., Cukrowská, B., Lodinová‐Žádníková, R., Kozáková, H., Rossmann, P., Bártová, J., Sokol, D., et al. (2004) · Immunology Letters · doi:10.1016/j.imlet.2004.02.005 · Cited by 755 · see citing works
Monostrain, multistrain and multispecies probiotics—A comparison of functionality and efficacy
Timmerman, H. M., Koning, C. J. M., Mulder, L., Rombouts, F. M., & Beynen, A. C. (2004) · International Journal of Food Microbiology · doi:10.1016/j.ijfoodmicro.2004.05.012 · Cited by 631 · see citing works
Kim, H. J., Camilleri, M., Mckinzie, S., Lempke, M. B., Burton, D. D., Thomforde, G. M., & Zinsmeister, A. R. (2003) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.2003.01543.x · Cited by 468 · see citing works
The functional gastrointestinal disorders
Olden, K. W. (1997) · General Hospital Psychiatry · doi:10.1016/s0163-8343(96)00109-0 · Cited by 439 · see citing works
Quality assurance criteria for probiotic bacteria
Tuomola, E., Crittenden, R. G., PLAYNE, M. J., Isolauri, E., & Salminen, S. (2001) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/73.2.393s · Cited by 432 · see citing works
Probiotic agents and infectious diseases: a modern perspective on a traditional therapy
Alvarez-Olmos, M. I., & Oberhelman, R. A. (2001) · Clinical Infectious Diseases · doi:10.1086/320518 · Cited by 359 · see citing works
Rosenfeldt, V., Benfeldt, E., Valerius, N. H., Pærregaard, A., & Michaelsen, K. F. (2004) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2004.06.068 · Cited by 326 · see citing works
Functional food concept and its application to prebiotics
Roberfroid, M. B. (2002) · Digestive and Liver Disease · doi:10.1016/s1590-8658(02)80176-1 · Cited by 324 · see citing works
Sporeformers as Human Probiotics: Bacillus, Sporolactobacillus , and Brevibacillus
Sanders, M. E., Morelli, L., & Tompkins, T. A. (2003) · Comprehensive Reviews in Food Science and Food Safety · doi:10.1111/j.1541-4337.2003.tb00017.x · Cited by 315 · see citing works
Gut bacteria and health foods—the European perspective
Saarela, M., Lähteenmäki, L., Crittenden, R. G., Salminen, S., & Mattila, T. (2002) · International Journal of Food Microbiology · doi:10.1016/s0168-1605(02)00235-0 · Cited by 313 · see citing works
The functional gastrointestinal disorders and the Rome II process
Drossman, D. A. (1999) · Gut · doi:10.1136/gut.45.2008.ii1 · Cited by 313 · see citing works
N UTRITIONAL I MPACT OF P RE- AND P ROBIOTICS AS P ROTECTIVE G ASTROINTESTINAL O RGANISMS
Teitelbaum, J. E., & Walker, W. A. (2002) · Annual Review of Nutrition · doi:10.1146/annurev.nutr.22.110901.145412 · Cited by 298 · see citing works
Isolauri, E. (2001) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/73.6.1142s · Cited by 291 · see citing works
Protective nutrients and functional foods for the gastrointestinal tract
Duggan, C., Gannon, J. L., & Walker, W. A. (2002) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/75.5.789 · Cited by 276 · see citing works
Intestinal permeability, leaky gut, and intestinal disorders
Hollander, D. (1999) · Current Gastroenterology Reports · doi:10.1007/s11894-999-0023-5 · Cited by 255 · see citing works
Pinchuk, I. V., Bressollier, P., Verneuil, B., Fenêt, B., Sorokulova, I. B., Mégraud, F., & Urdaci, M. C. (2001) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.45.11.3156-3161.2001 · Cited by 252 · see citing works
Plummer, S. F., Weaver, M. A., Harris, J. C., Dee, P., & Hunter, J. O. (2004) · PubMed · Cited by 251 · see citing works
Hoa, N. T., Baccigalupi, L., Huxham, A., Smertenko, A., Vân, P. H., Ammendola, S., Ricca, E., & Cutting, S. M. (2000) · Applied and Environmental Microbiology · doi:10.1128/aem.66.12.5241-5247.2000 · Cited by 249 · see citing works
Indications for referral and assessment in adultliver transplantation: a clinical guideline
Devlin, J., & O’Grady, J. (1999) · Gut · doi:10.1136/gut.45.2008.vi1 · Cited by 243 · see citing works
Sanderson, I. R., & Walker, W. A. (1993) · Gastroenterology · doi:10.1016/0016-5085(93)90436-g · Cited by 241 · see citing works
Intestinal Permeability Test As A Predictor of Clinical Course in Crohn's Disease
Renata D'Incà, Leo, V. D., Corrao, G., Martines, D., D’Odorico, A., Mestriner, C., Venturi, C., Longo, G., & Sturniolo, G. C. (1999) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.1999.01444.x · Cited by 218 · see citing works
Probiotics: what are they? What are their effects on gut physiology?
Fioramonti, J., Théodorou, V., & Bueno, L. P. (2003) · Best Practice & Research Clinical Gastroenterology · doi:10.1016/s1521-6918(03)00075-1 · Cited by 212 · see citing works
Probiotics and medical nutrition therapy.
Brown, A. C., & Valiere, A. (2004) · PubMed · Cited by 205 · see citing works
Ballard, S. T., Hunter, J. H., & Taylor, A. E. (1995) · Annual Review of Nutrition · doi:10.1146/annurev.nu.15.070195.000343 · Cited by 193 · see citing works
A working hypothesis for the etiology and pathogenesis of nonspecific inflammatory bowel disease
Shorter, R. G., Huizenga, K. A., & Spencer, R. J. (1972) · Digestive Diseases and Sciences · doi:10.1007/bf02239143 · Cited by 176 · see citing works
Probiotics in The Treatment of Irritable Bowel Syndrome
Saggioro, A. (2004) · Journal of Clinical Gastroenterology · doi:10.1097/01.mcg.0000129271.98814.e2 · Cited by 176 · see citing works
A review of the role of the gut microflora in irritable bowel syndrome and the effects of probiotics
Madden, J. A. J., & Hunter, J. O. (2002) · British Journal Of Nutrition · doi:10.1079/bjn2002631 · Cited by 174 · see citing works
The use of probiotics in medical practice
Mombelli, B., & Gismondo, M. R. (2000) · International Journal of Antimicrobial Agents · doi:10.1016/s0924-8579(00)00322-8 · Cited by 172 · see citing works
Warner-Lambert/Parke-Davis Award lecture. Pathobiology of the intestinal epithelial barrier.
Jl, M. (1990) · PubMed · Cited by 153 · see citing works
Probiotics and prebiotics in gastrointestinal disorders
Fedorak, R. N., & Madsen, K. L. (2004) · Current Opinion in Gastroenterology · doi:10.1097/00001574-200403000-00017 · Cited by 148 · see citing works
Healthy gut microflora and allergy: factors influencing development of the microbiota
Kirjavainen, P. V., & Gibson, G. R. (1999) · Annals of Medicine · doi:10.3109/07853899908995892 · Cited by 138 · see citing works
Hosoi, T., Ametani, A., Kiuchi, K., & Kaminogawa, S. (2000) · Canadian Journal of Microbiology · doi:10.1139/w00-070 · Cited by 131 · see citing works
Hertkorn, N., Permin, A. B., Perminova, I. V., Kovalevskii, D. V., Yudov, M., Petrosyan, V. S., & Kettrup, A. (2002) · Journal of Environmental Quality · doi:10.2134/jeq2002.3750 · Cited by 125 · see citing works
Functional gastrointestinal disorders
Hyams, J. S. (1999) · Current Opinion in Pediatrics · doi:10.1097/00008480-199910000-00001 · Cited by 115 · see citing works
Diagnosing and Treating Patients with Refractory Functional Gastrointestinal Disorders
Drossman, D. A. (1995) · Annals of Internal Medicine · doi:10.7326/0003-4819-123-9-199511010-00008 · Cited by 89 · see citing works
Bjarnason, I. (1994) · Gut · doi:10.1136/gut.35.1_suppl.s18 · Cited by 83 · see citing works
Intestinal permeability is increased in bronchial asthma
Hijazi, Z. (2004) · Archives of Disease in Childhood · doi:10.1136/adc.2003.027680 · Cited by 79 · see citing works
Taxonomic Study of Bacillus coagulans Hammer 1915 with a Proposal for Bacillus smithii sp. nov.
Nakamura, L. K., BLUMENSTOCK, I., & Claus, D. (1988) · International Journal of Systematic Bacteriology · doi:10.1099/00207713-38-1-63 · Cited by 71 · see citing works
Uil, J. J., van Elburg, R. M., van Overbeek, F. M., Mulder, C. J. J., Henegouwen, G. P. V. B., & Heymans, H. S. A. (1997) · PubMed · Cited by 70 · see citing works
Increased gastric and intestinal permeability in patients with Crohn's disease.
Wyatt, J., Oberhuber, G., Pongratz, S., et al. (1997) · PubMed · Cited by 66 · see citing works
Changes in Gastrointestinal Permeability in Celiac Disease
Vogelsang, H., Schwarzenhofer, M., & Oberhuber, G. (1998) · Digestive Diseases · doi:10.1159/000016886 · Cited by 62 · see citing works
Damiano, A. M., Handley, K., Adler, E., Siddique, R. M., & Bhattacharyja, A. (2002) · Digestive Diseases and Sciences · doi:10.1023/a:1015815102175 · Cited by 60 · see citing works
The Role of Probiotics in the Clinical Management of Food Allergy and Atopic Dermatitis
del Giudice, M. M., & Luca, M. G. D. (2004) · Journal of Clinical Gastroenterology · doi:10.1097/01.mcg.0000133293.18576.d2 · Cited by 51 · see citing works
Young, R. J., & Huffman, S. L. (2003) · Journal of Pediatric Health Care · doi:10.1016/s0891-5245(03)00070-1 · Cited by 47 · see citing works
Bovee-Oudenhoven, I. M. J., Termont, D. S., Dekker, R., & van der Meer, R. (1996) · Gut · doi:10.1136/gut.38.1.59 · Cited by 47 · see citing works
Inventing probiotic functional foods for patients with allergic disease
Laiho, K., Ouwehand, A. C., Salminen, S., & Isolauri, E. (2002) · Annals of Allergy Asthma & Immunology · doi:10.1016/s1081-1206(10)62128-x · Cited by 46 · see citing works
Lactulose-Mannitol Intestinal Permeability Test: A Useful Screening Test for Adult Coeliac Disease
Johnston, S. D., Smye, M. G., Watson, R. G. P., McMillan, S. A., Trimble, E. R., & Love, A. H. (2000) · Annals of Clinical Biochemistry International Journal of Laboratory Medicine · doi:10.1177/000456320003700413 · Cited by 46 · see citing works
Probiotics and functional foods in gastrointestinal disorders
Floch, M. H., & Hong-Curtis, J. (2002) · Current Treatment Options in Gastroenterology · doi:10.1007/s11938-002-0054-6 · Cited by 45 · see citing works
Cross, M. L. (2004) · International Journal of Immunopathology and Pharmacology · doi:10.1177/039463200401700204 · Cited by 45 · see citing works
Urine Indican Excretion in Malabsorptive Disorders
Greenberger, N. J., Saegh, S., & Ruppert, R. D. (1968) · Gastroenterology · doi:10.1016/s0016-5085(19)34071-5 · Cited by 44 · see citing works
The Bifidobacterial and Lactobacillus Microflora of Humans
Tannock, G. W. (2002) · Clinical Reviews in Allergy & Immunology · doi:10.1007/s12016-002-0010-1 · Cited by 35 · see citing works
Role of probiotics in the management of patients with food allergy
Vanderhoof, J. A., & Young, R. J. (2003) · Annals of Allergy Asthma & Immunology · doi:10.1016/s1081-1206(10)61669-9 · Cited by 35 · see citing works
Sorption of Polycyclic Aromatic Compounds to Humic and Fulvic Acid HPLC Column Materials
Kollist‐Siigur, K., Nielsen, T., Gr⊘n, C., et al. (2001) · Journal of Environmental Quality · doi:10.2134/jeq2001.302526x · Cited by 29 · see citing works
Lactulose–mannitol intestinal permeability test: a useful screening test for adult coeliac disease
Johnston, S. D., Smye, M. G., Watson, R. G. P., et al. (2000) · Annals of Clinical Biochemistry International Journal of Laboratory Medicine · doi:10.1258/0004563001899500 · Cited by 29 · see citing works
Hirabayashi, M., Matsui, T., & Hldeo, Y. A. N. O. (1998) · Journal of Nutritional Science and Vitaminology · doi:10.3177/jnsv.44.877 · Cited by 26 · see citing works
Preclinical and Clinical Pharmacology of Biotherapeutic Agents:Saccharomyces boulardii
Periti, P., & Tonelli, F. (2001) · Journal of Chemotherapy · doi:10.1179/joc.2001.13.5.473 · Cited by 25 · see citing works
Lactulose/Mannitol Test Has High Efficacy for Excluding Organic Causes of Chronic Diarrhea
Leo, V. D., Renata D'Incà, Diaz-Granado, N., Fries, W., Venturi, C., D’Odorico, A., Martines, D., & Sturniolo, G. C. (2003) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2003.07697.x · Cited by 25 · see citing works
Gastrointestinal allergy to food: a review.
Ahmed, T., & Fuchs, G. J. (1997) · PubMed · Cited by 21 · see citing works
Cucchiara, S., Falconieri, P., Nardo, G. D., Porcelli, M. A., Dito, L., & Grandinetti, A. (2002) · Digestive and Liver Disease · doi:10.1016/s1590-8658(02)80163-3 · Cited by 21 · see citing works
Knutson, T. W., Bengtsson, U. J., Dannaeus, A., et al. (1996) · Journal of Allergy and Clinical Immunology · doi:10.1016/s0091-6749(96)70189-6 · Cited by 21 · see citing works
Novel probiotics for the management of allergic inflammation
von der Weid, T., Ibnou-Zekri, N., & Pfeifer, A. (2002) · Digestive and Liver Disease · doi:10.1016/s1590-8658(02)80159-1 · Cited by 18 · see citing works
New food components and gastrointestinal health
Johnson, I. T. (2001) · Proceedings of The Nutrition Society · doi:10.1079/pns2001106 · Cited by 17 · see citing works
Hosoi, T., Ametani, A., Kiuchi, K., et al. (2000) · Canadian Journal of Microbiology · doi:10.1139/cjm-46-10-892 · Cited by 10 · see citing works
Systematic Approach toward the Clinical Diagnosis of Functional Dyspepsia
Paré, P. (1999) · Canadian Journal of Gastroenterology and Hepatology · doi:10.1155/1999/309676 · Cited by 8 · see citing works
Glise, H. (1998) · The European Journal of Surgery · doi:10.1080/11024159850191274 · Cited by 5 · see citing works
The Role of Quality of Life in Functional Gastrointestinal Disorders: Regulatory Issues
Bergmann, J. (1998) · The European Journal of Surgery · doi:10.1080/11024159850191319 · Cited by 5 · see citing works
The Bifidobacterial and Lactobacillus Microflora of Humans
Tannock, G. W. (2002) · Clinical Reviews in Allergy & Immunology · doi:10.1385/criai:22:3:231 · Cited by 4 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Gut microbiota role in irritable bowel syndrome: New therapeutic strategies
Distrutti, E., Monaldi, L., Ricci, P., & Fiorucci, S. (2016) · World Journal of Gastroenterology · doi:10.3748/wjg.v22.i7.2219 · Cited by 320 · see citing works
Hungin, A. P. S., Mulligan, C., Pot, B., Whorwell, P., Agréus, L., Fracasso, P., Lionis, C., Mendive, J., Philippart de Foy, J.-M., Rubin, G., et al. (2013) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.12460 · Cited by 212 · see citing works
Hungin, A. P. S., Mitchell, C. R., Whorwell, P., Mulligan, C., Cole, O., Agréus, L., Fracasso, P., Lionis, C., Mendive, J., Philippart de Foy, J. ‐., et al. (2018) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14539 · Cited by 154 · see citing works
Schmulson, M., & Chang, L. (2011) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2011.04637.x · Cited by 70 · see citing works
- Authors
- S. Kim, L., Hilli, L., Orlowski, J., Kupperman, J. L., Baral, M., & F. Waters, R.
- Affiliations
- Southwest College of Naturopathic Medicine & Health Sciences (US)
- Venue
- Digestive Diseases and Sciences
- Published
- 2006-11-01
- Volume
- 51
- Issue
- 12
- Pages
- 2134-2144
- ISSN
- 0163-2116 (ISSN-L)
- 1573-2568
- OpenAlex
- W1973338669
- Cited by
- 30
- References
- 78
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 1 · 2022: 5 · 2021: 1 · 2020: 2 · 2018: 3 · 2016: 2 · 2015: 1 · 2014: 1 · 2013: 1
- FWCI
- 1.21
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Digestive Diseases and Sciences (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- probiotics, functional gastrointestinal disorders, dietary nutrients, dyspepsia, bloating, abdominal discomfort, gastrointestinal quality of life
- MeSH terms
- Adult, Aged, Double-Blind Method, Dyspepsia, Female, Gastrointestinal Diseases, Humans, Indican, Male, Middle Aged, Pain Measurement, Pilot Projects, Plant Extracts, Quality of Life, Abdominal Pain, Dietary Supplements, Probiotics
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
