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Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial
Open accessAbstract
Background & aims Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder associated with intestinal dysbiosis. Given the reported promising results of open-label fecal microbiota transplantation (FMT) therapy in patients with predominant abdominal bloating, we studied efficacy of this treatment in a randomized, placebo-controlled trial.Methods Patients with refractory IBS, defined as failure of ≥3 conventional therapies, were randomly assigned to single-dose nasojejunal administration of donor stools (n = 43) or autologous stools (n = 19) in a double-blind study, performed from December 2015 through October 2017, and were followed up for 1 year. IBS-related symptoms were assessed by using a daily symptom diary to determine general abdominal discomfort, abdominal bloating, abdominal pain, and flatulence on a scale of 1-6. Number of daily bowel movements, consistency of the stools, and abdominal circumference were also recorded. Patients completed the IBS-specific quality of life questionnaire. Primary endpoints were improvement of IBS symptoms and bloating at 12 weeks (response). Secondary endpoints were changes in IBS symptom scores and quality of life. Stool samples were collected for microbiota amplicon sequencing. Open-label retransplantation was offered after the trial.Results At week 12, 56% of patients given donor stool reported improvement in both primary endpoints compared with 26% of patients given placebo (P = .03). Patients given donor stool had significant improvements in level of discomfort (mean reduction, 19%; median score before FMT, 3.98; range, 2.13-6.00; median score after FMT, 3.1; range, 951.29-5.90), stool frequency (mean reduction, 13%; median score before FMT, 2.10; range, 0.57-14.29; median score after FMT 1.7; range, 0.71-4.29), urgency (mean reduction, 38%; median score before FMT, 0.61; range, 0.00-1.00; median score after FMT, 0.37; range, 0.00-1.00), abdominal pain (mean reduction, 26%; median score before FMT, 3.88; range, 1.57-5.17; median score after FMT, 2.80; range, 1.14-4.94), flatulence (mean reduction, 10%; median score before FMT, 3.42; range, 0.71-6.00; median score after FMT, 3.07; range, 0.79-4.23), and quality of life (mean increase, 16%; median score before FMT 32.6; range, 11-119; median score after FMT, 43.1; range, 32.25-99). A significantly higher proportion of women given donor stool (69%) had a response than men (29%) (P = .01). Fecal samples from responders had higher diversity of microbiomes before administration of donor material than fecal samples from nonresponders (P = .04) and distinct baseline composition (P = .04), but no specific marker taxa were associated with response. After single FMT, 21% of patients given donor stool reported effects that lasted for longer than 1 year compared with 5% of patients given placebo stool. A second FMT reduced symptoms in 67% of patients with an initial response to donor stool but not in patients with a prior nonresponse.Conclusions In a randomized trial of patients with treatment-refractory IBS with predominant bloating, FMT relieved symptoms compared with placebo (autologous transplant), although the effects decreased over 1 year. A second FMT restored the response patients with a prior response. Response was associated with composition of the fecal microbiomes before FMT; this might be used to as a biomarker to select patients for this treatment. ClinicalTrials.gov, Number: NCT02299973.
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“In addition, the extent of FMT engraftment in recipient mice may be influenced by the gender of the recipients.”
From Microbiota–gut–brain axis and its therapeutic applications in neurodegenerative diseases (2024) · cites this paper as [732]
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“Similar sexual dimorphism of FMT has been reported in a clinical trial of irritable bowel syndrome, wherein female patients exhibit significantly better responses compared to male patients.732”
From Microbiota–gut–brain axis and its therapeutic applications in neurodegenerative diseases (2024) · cites this paper as [732]
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Abdelghafar, Y. A., AbdelQadir, Y. H., Motawea, K. R., Nasr, S. A., Omran, H. A. M., Belal, M. M., Elhashash, M. M., AbdelAzim, A. A., & Shah, J. (2022) · Health Science Reports · doi:10.1002/hsr2.814 · Cited by 21
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Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome Patients
Elhusein, A. M., & Fadlalmola, H. A. (2022) · Gastroenterology Nursing · doi:10.1097/sga.0000000000000652 · Cited by 18
Browne, P. D., Cold, F., Petersen, A. M., Halkjær, S. I., Christensen, A. H., Günther, S., & Hansen, L. H. (2021) · Gut Microbes · doi:10.1080/19490976.2021.1927635 · Cited by 18
Ткач, С. М., Dorofeyev, A., Kuzenko, I., Falalyeyeva, T. M., Tsyryuk, O., Kovalchuk, O. I., Kobyliak, N. M., Abenavoli, L., & Boccuto, L. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2022.1049849 · Cited by 19
Belgian consensus on irritable bowel syndrome
Kindt, S., Louis, H., Schepper, H. U. D., Arts, J., Caenepeel, P., Looze, D. A. D., Gerkens, A., Holvoet, T., Latour, P., Mahler, T., et al. (2022) · Acta gastro-enterologica belgica · doi:10.51821/85.2.10100 · Cited by 21
Self-citationEl‐Salhy, M., Mazzawi, T. R. E., Hausken, T., & Hatlebakk, J. G. (2022) · Scandinavian Journal of Gastroenterology · doi:10.1080/00365521.2022.2064725 · Cited by 18
“four of which showed a positive effect [8,9,18,22] while the other three showed no effect [19–21].”
BackgroundInfluentialEl‐Salhy, M., Gilja, O. H., & Hatlebakk, J. G. (2023) · Neurogastroenterology & Motility · doi:10.1111/nmo.14641 · Cited by 16
Wang, Y., Hu, Y., & Shi, P. (2024) · BMC Gastroenterology · doi:10.1186/s12876-024-03311-x · Cited by 19
“At 52 weeks, the three studies [42, 45, 46]that reported long term outcomes, 33.9% global improvement in IBS symptoms (41/121) in patients who received donor FMT, 24.7% (18/73) in patients who received a placebo.”
BackgroundMethodResultInfluentialResearch Progress in Fecal Microbiota Transplantation as Treatment for Irritable Bowel Syndrome
Wang, Y., Zheng, F., Liu, S., & Luo, H. (2019) · Gastroenterology Research and Practice · doi:10.1155/2019/9759138 · Cited by 16
Karimianghadim, R., Satokari, R. M., Yeo, S., Arkkila, P. E. T., Kao, D. H., & Pakpour, S. (2025) · Frontiers in Microbiology · doi:10.3389/fmicb.2025.1589704 · Cited by 17
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“The host gut microbiota contributes to the etiology and symptomology of IBS,([24,25]) which are associated with increased epithelial permeability and aberrations in immunity.”
BackgroundInfluentialТкач, С. М., Dorofeyev, A., Kuzenko, I., Sulaieva, O., Falalyeyeva, T. M., & Kobyliak, N. M. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.994911 · Cited by 15
Management of irritable bowel syndrome: a narrative review
Tetali, B., & Suresh, S. (2024) · Translational Gastroenterology and Hepatology · doi:10.21037/tgh-23-96 · Cited by 15
“However, long-term efficacy seems to be limited, with only transient symptom relief initially, followed by a return of symptoms within 3-to 12-month (38,39).”
BackgroundYao, C., Li, Y., Luo, L., Xie, F., Xiong, Q., Li, T., Yang, C., & Feng, P. (2022) · Digestive Diseases and Sciences · doi:10.1007/s10620-022-07500-0 · Cited by 17
“Fecal microbiota transplantation (FMT) [18], probiotics [19], and antibiotic [20] therapy can effectively improve the symptoms of IBS patients, which also demonstrate the important role of gut microbiota in the pathogenesis of IBS.”
BackgroundInfluentialGastrointestinal disorders and intestinal bacteria: Advances in research and applications in therapy
Ohkusa, T., Nishikawa, Y., & Sato, N. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2022.935676 · Cited by 16
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Arbeláez, M. C. S., Monshine, J., Porto, J. G., Shah, K. H., Singh, P. K., Roy, S., Amin, K. A., Marcovich, R., Herrmann, T. R. W., & Shah, H. N. (2023) · World Journal of Urology · doi:10.1007/s00345-023-04588-5 · Cited by 14
“Moreover, this associated with pathologies in which microbiome dysbiosis has been detected, such as irritable bowel syndrome [16, 17], raised the doubt of whether changes in human microbiota could better explain CPPS etiology and potentially help to better establish its treatment.”
BackgroundFecal microbiota transplantation-current perspective on human health
Cao, Z., Gao, T., Bajinka, O., Zhang, Y., & Yuan, X. (2025) · Frontiers in Medicine · doi:10.3389/fmed.2025.1523870 · Cited by 14
What is unknown in using microbiota as a therapeutic?
Sung, J. J. �., & Wong, S. H. (2021) · Journal of Gastroenterology and Hepatology · doi:10.1111/jgh.15716 · Cited by 14
Therapeutic Potential of Short-Chain Fatty Acids in Gastrointestinal Diseases
Zhu, M., & Lee, J. W. J. (2025) · Nutraceuticals · doi:10.3390/nutraceuticals5030019 · Cited by 15
“Although the effects diminished over a year, a second FMT was able to restore symptom relief in patients who had previously responded [86].”
Clinical trials targeting the gut-microbiome to effect ocular health: a systematic review
Russell, M. W., Muste, J. C., Kuo, B. L., Wu, A. K., & Singh, R. P. (2023) · Eye · doi:10.1038/s41433-023-02462-7 · Cited by 13
Methods of Determining Irritable Bowel Syndrome and Efficiency of Probiotics in Treatment: A Review
Ahlawat, G. M., & Singh, P. K. (2023) · Current Therapeutic Research · doi:10.1016/j.curtheres.2023.100721 · Cited by 13
Feng, M., Zou, Z., Shou, P., Peng, W., Liu, M., & Li, X. (2024) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2024.1479343 · Cited by 14
Huang, K., Wu, L., & Yang, Y. (2021) · JGH Open · doi:10.1002/jgh3.12659 · Cited by 13
Current perspectives on irritable bowel syndrome: a narrative review
Hojo, M., & Nagahara, A. (2022) · Journal of International Medical Research · doi:10.1177/03000605221126370 · Cited by 13
“In recent years, a double-blind, randomized controlled trial of donor and placebo stool (autologous stool) transplantation was conducted in IBS patients with abdominal distension as the main symptom.(15) At the 3-month post-transplantation assessment, IBS symptoms improved in 56% of patients who underwent donor fecal…”
BackgroundRamos, G. P., & Camilleri, M. (2022) · Digestive Diseases and Sciences · doi:10.1007/s10620-022-07700-8 · Cited by 14
Hypnotherapy and IBS: Implicit, long-term stress memory in the ENS?
Császár-Nagy, N., & Bókkon, I. (2022) · Heliyon · doi:10.1016/j.heliyon.2022.e12751 · Cited by 17
Sun, X., Zhou, X., He, W., Sun, W., & Xu, Z. M. (2023) · Drug Design Development and Therapy · doi:10.2147/dddt.s443462 · Cited by 12
“70,71 Notably, delivery routes have differences in effectiveness for the treatment of related conditions (eg, recurrent CDI, 72 IBD, 73 diarrhea, 74 and IBS 75–78 ).”
BackgroundNeuropathy in COVID-19 associated with dysbiosis-related inflammation
Aktaş, B., & Aslım, B. (2021) · TURKISH JOURNAL OF BIOLOGY · doi:10.3906/biy-2105-53 · Cited by 12
“…nervous system have been shown to play an important role in irritable bowel syndrome (IBS) pathogenesis and associated functional gastrointestinal disorders with GI manifestations such as abdominal pain, diarrhea, or/and constipation (Mari et al., 2020; Simpson et al., 2020; Holvoet et al., 2021).”
BackgroundResultPotential of natural products in the treatment of irritable bowel syndrome
Lü, Q., Tan, D., Luo, J., Ye, Y., Zuo, M., Wang, S., & Li, C. (2022) · Phytomedicine · doi:10.1016/j.phymed.2022.154419 · Cited by 12
Irritable bowel syndrome patients who are not likely to respond to fecal microbiota transplantation
El‐Salhy, M., Mazzawi, T. R. E., Hausken, T., & Hatlebakk, J. G. (2022) · Neurogastroenterology & Motility · doi:10.1111/nmo.14353 · Cited by 11
Strain-level genetic heterogeneity and colonization dynamics drive microbiome therapeutic efficacy
Chen, K., Liu, Y., Rong, J., Dai, N., Xu, C., Li, H., Zhong, L., Wang, B., Ji, Z., Xie, S., et al. (2026) · Cell Host & Microbe · doi:10.1016/j.chom.2026.02.002 · Cited by 12
Metadata
- Authors
- Holvoet, T., Joossens, M., Vázquez-Castellanos, J. F., Christiaens, E., Heyerick, L., Boelens, J., Verhasselt, B., van Vlierberghe, H., De Vos, M., Raes, J., & De Looze, D.
- Affiliations
- Ghent University Hospital (BE)
- VIB-KU Leuven Center for Microbiology (BE)
- Corresponding author
- Holvoet, Tom
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2021-01
- Volume
- 160
- Issue
- 1
- Pages
- 145-157.e8
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W3043347255
- Cited by
- 201
- References
- 37
- Citations by year
- 2026: 17 · 2025: 24 · 2024: 36 · 2023: 40 · 2022: 50 · 2021: 21
- FWCI
- 24.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Lirias (KU Leuven) (submittedVersion, other-oa)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Funders
- Fonds Wetenschappelijk Onderzoek
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Keywords
- fecal microbiota transplantation, irritable bowel syndrome, bloating, gut dysbiosis, symptom improvement, stool consistency, abdominal circumference, retransplantation, long-term outcomes, abdominal pain, flatulence
- MeSH terms
- Fecal Microbiota Transplantation, Adolescent, Adult, Double-Blind Method, Female, Flatulence, Humans, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Time Factors, Abdominal Pain, Treatment Outcome, Irritable Bowel Syndrome, Young Adult
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