Design of Treatment Trials for Functional Gastrointestinal Disorders

Irvine, E. Jan; Tack, Jan; Crowell, Michael D.; Gwee, Kok Ann; Ke, Meiyun; Schmulson, Max J.; Whitehead, William E.; Spiegel, Brennan

doi:10.1053/j.gastro.2016.02.010

Cited by 550Gastrointestinal motility and disordersStatistical Methods in Clinical TrialsEthics in Clinical Research

Design of Treatment Trials for Functional Gastrointestinal Disorders

Irvine, E. Jan, Tack, Jan, Crowell, Michael D., Gwee, Kok Ann, Ke, Meiyun, Schmulson, Max J., Whitehead, William E., Spiegel, Brennan·2016·Gastroenterology

DOI 10.1053/j.gastro.2016.02.010

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Abstract

This article summarizes recent progress and regulatory guidance on design of trials to assess the efficacy of new therapies for functional gastrointestinal disorders (FGIDs). The double-masked, placebo-controlled, parallel-group design remains the accepted standard for evaluating treatment efficacy. A control group is essential, and a detailed description of the randomization process and concealed allocation method must be included in the study report. The control will most often be placebo, but for therapeutic procedures and for behavioral treatment trials, respectively, a sham procedure and control intervention with similar expectation of benefit, but lacking the treatment principle, are recommended. Investigators should be aware of, and attempt to minimize, expectancy effects (placebo, nocebo, precebo). The primary analysis should be based on the proportion of patients in each treatment arm who satisfy a treatment responder definition or a prespecified clinically meaningful change in a patient-reported outcome measure. Data analysis should use the intention-to-treat principle. Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include secondary outcome measures to support or explain the primary outcome and an analysis of harms data. Trials should be registered in a public location before initiation and results should be published regardless of outcome.

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Crossref · 10.1053/j.gastro.2016.02.010

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A 12-week period is recommended by guidelines for the design of treatment trials in IBS.
“which is recommended by guidelines for the design of treatment trials in IBS. 38”
From Efficacy of Probiotics in Irritable Bowel Syndrome: Systematic Review and Meta-analysis (2023) · cites this paper as [38]

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Prebiotic effects: metabolic and health benefits
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Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial.
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Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders 1 1This study was registered with ClinicalTrials.gov (trial registry no. NCT00006157).
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Diet Low in FODMAPs Reduces Symptoms of Irritable Bowel Syndrome as Well as Traditional Dietary Advice: A Randomized Controlled Trial
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Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome
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Tegaserod, a 5‐HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation
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Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low <scp>FODMAP</scp> diet in children with the irritable bowel syndrome
Chumpitazi, B. P., Cope, J. L., Hollister, E. B., Tsai, C. M., McMeans, A. R., Luna, R. A., Versalovic, J., & Shulman, R. J. (2015) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.13286 · Cited by 436 · see citing works
Fiber and Functional Gastrointestinal Disorders
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A diet low in FODMAPs reduces symptoms in patients with irritable bowel syndrome and a probiotic restores bifidobacterium species: a randomized controlled trial
Staudacher, H. M., Lomer, M. C. E., Farquharson, F. M., Louis, P., Fava, F., Franciosi, E., Scholz, M., Tuohy, K. M., Lindsay, J. O., Irving, P. M., et al. (2017) · Gastroenterology · doi:10.1053/j.gastro.2017.06.010 · Cited by 430 · see citing works
Effect of antidepressants and psychological therapies, including hypnotherapy, in irritable bowel syndrome: systematic review and meta-analysis
Ford, A. C., Quigley, E. M. M., Lacy, B. E., Lembo, A. J., Saito, Y. A., Schiller, L. R., Soffer, E. E., Spiegel, B. M. R., & Moayyedi, P. (2014) · American Journal of Gastroenterology · doi:10.1038/ajg.2014.148 · Cited by 405 · see citing works
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American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome
Ford, A. C., Moayyedi, P., Chey, W. D., Harris, L. A., Lacy, B. E., Saito, Y. A., & Quigley, E. M. M. (2018) · American Journal of Gastroenterology · doi:10.1038/s41395-018-0084-x · Cited by 388 · see citing works
Meta‐analysis of smooth muscle relaxants in the treatment of irritable bowel syndrome
Poynard, T., Regimbeau, C., & Benhamou, Y. (2001) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.2001.00937.x · Cited by 405 · see citing works
Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT
Barichella, M., Pacchetti, C., Bolliri, C., Cassani, E., Iorio, L., Pusani, C., Pinelli, G., Privitera, G., Cesari, I., Faierman, S. A., et al. (2016) · Neurology · doi:10.1212/wnl.0000000000003127 · Cited by 390 · see citing works
Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome
Ruepert, L., Quartero, A. O., de Wit, N. J., van der Heijden, G. J., Rubin, G., & Muris, J. W. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003460.pub3 · Cited by 389 · see citing works
Clinical trial: multispecies probiotic supplementation alleviates the symptoms of irritable bowel syndrome and stabilizes intestinal microbiota
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Effect of a fermented milk containing Bifidobacterium animalis DN‐173 010 on the health‐related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double‐blind, controlled trial
GUYONNET, D., CHASSANY, O., DUCROTTE, P., PICARD, C., MOURET, M., MERCIER, C. ‐., & MATUCHANSKY, C. (2007) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2007.03362.x · Cited by 365 · see citing works
The Utility of Probiotics in the Treatment of Irritable Bowel Syndrome: A Systematic Review
Brenner, D. M., Moeller, M. J., Chey, W. D., & Schoenfeld, P. S. (2009) · The American Journal of Gastroenterology · doi:10.1038/ajg.2009.25 · Cited by 362 · see citing works
A probiotic mixture alleviates symptoms in irritable bowel syndrome patients: a controlled 6‐month intervention
KAJANDER, K., HATAKKA, K., POUSSA, T., FÄRKKILÄ, M., & KORPELA, R. (2005) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2005.02579.x · Cited by 361 · see citing works
Systematic Review on the Management of Chronic Constipation in North America
Brandt, L. J., Prather, C. M., Quigley, E. M. M., Schiller, L. R., Schoenfeld, P., & Talley, N. J. (2005) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2005.50613_2.x · Cited by 342 · see citing works
Systematic review: the role of different types of fibre in the treatment of irritable bowel syndrome
Bijkerk, C. J., Muris, J. W. M., Knottnerus, J. A., Hoes, A. W., & de Wit, N. J. (2004) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.0269-2813.2004.01862.x · Cited by 325 · see citing works
Randomized, Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation
Heymen, S., Scarlett, Y. V., Jones, K., Ringel, Y., Drossman, D. A., & Whitehead, W. E. (2007) · Diseases of the Colon & Rectum · doi:10.1007/s10350-006-0814-9 · Cited by 321 · see citing works
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The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials
Dimidi, E., Christodoulides, S., Fragkos, K. C., Scott, S. M., & Whelan, K. (2014) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.114.089151 · Cited by 316 · see citing works
Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial
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Authors: Irvine, E. J., Tack, J., Crowell, M. D., Gwee, K. A., Ke, M., Schmulson, M. J., Whitehead, W. E., & Spiegel, B.
Affiliations: St. Michael's Hospital (CA)
Universitair Ziekenhuis Leuven (BE)
Mayo Clinic (US)
National University of Singapore (SG)
Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
Hospital General de México (MX)
University of North Carolina at Chapel Hill (US)
Cedars-Sinai Medical Center (US)
Corresponding author: Tack, Jan
ORCID: Tack, Jan
Crowell, Michael D.
Gwee, Kok Ann
Schmulson, Max J.
Whitehead, William E.
Spiegel, Brennan
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2016-05
Volume: 150
Issue: 6
Pages: 1469-1480.e1
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2016.02.010
OpenAlex: W2065994042
Cited by: 550
References: 151
Citations by year: 2026: 7 · 2025: 7 · 2024: 17 · 2023: 12 · 2022: 19 · 2021: 25 · 2020: 22 · 2019: 22 · 2018: 31 · 2017: 22 · 2016: 20 · 2015: 19 · 2014: 27 · 2013: 20 · 2012: 17
FWCI: 5.29
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Gastroenterology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: functional gastrointestinal disorders, clinical trial design, sham procedure, expectancy effects, nocebo, patient-reported outcome measures, intention-to-treat analysis, CONSORT guidelines, clinical trial registration, regulatory guidelines
MeSH terms: Gastrointestinal Diseases, Research Design

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Design of Treatment Trials for Functional Gastrointestinal Disorders

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