Cited by 201Gastrointestinal motility and disordersGut microbiota and healthInflammatory Bowel Disease

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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

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Holvoet, Tom, Joossens, Marie, Vázquez-Castellanos, Jorge F., Christiaens, Evelien, Heyerick, Lander, Boelens, Jerina, Verhasselt, Bruno, van Vlierberghe, Hans, De Vos, Martine, Raes, Jeroen, De Looze, Danny·2021·Gastroenterology

DOI 10.1053/j.gastro.2020.07.013

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Abstract

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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Influential
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Method
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A laboratory-less nomogram predicting survival rates for hospice patients with advanced cancer
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“Clinician prediction of survival (CPS) is often inaccurate, and uncertainty about prognosis diminishes the quality of doctor-patient communication, potentially resulting in more aggressive hospice care [9–11], Consequently, objective prediction tools with high accuracy are vital in hospice care.”
Revisiting Data Visualizations in Diagnostic Reports
Buono, P., Tamla, P., Krause, T., Luzi, F. D., Monti, F., & Mecella, M. (2025) · IEEE International Conference on Bioinformatics and Biomedicine (BIBM) · doi:10.1109/bibm66473.2025.11356146 · Cited by 2
Pre-Antibiotic Treatment Followed by Prolonged Repeated Faecal Microbiota Transplantation Improves Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome: An Observational Australian Clinical Experience
Hamblin, H. S., Gunaratne, A. W., Clancy, A. K., Pilarinos, D., Busque, A. L., Dawson, M. V. M., & Borody, T. J. (2022) · Gastroenterology Research and Practice · doi:10.1155/2022/6083896 · Cited by 2
“Larger RCTs which have examined the role of FMT delivered via single colonoscopic/gastroscopic infusions have demonstrated in IBS both symptomatic improvement and gut microbial compositional changes when compared with placebo [24–27].”
BackgroundInfluential
Topic: Nutrition and the Gut-Liver-Brain Axis
Ho, A. H. Y., Wong, S. H., & Lui, R. N.-S. (2022) · Current Hepatology Reports · doi:10.1007/s11901-022-00589-x · Cited by 3
Fecal Microbiota Transplantation in Diseases Not Associated with Clostridium difficile: Current Status and Future Therapeutic Option
Ткач, С. М., Dorofeyev, A., Kuzenko, I., Boyko, N., Falalyeyeva, T. M., & Kobyliak, N. M. (2023) · Advances in predictive, preventive and personalised medicine · doi:10.1007/978-3-031-19564-8_10 · Cited by 2
Transplanting Microbes for Irritable Bowels or Irritated Microbes or Both?
O’Toole, P. W., & Shanahan, F. (2020) · Gastroenterology · doi:10.1053/j.gastro.2020.10.023 · Cited by 2
Editorial: Faecal microbiota transplantation in IBS —Moving closer or away from success?
Lesmana, E., & Grover, M. (2023) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17724 · Cited by 2
Recommendations for the diagnosis and management of patients with chronic idiopathic diarrhea: Belgian multidisciplinary expert discussion based on a modified Delphi method
Vanuytsel, T., Arts, J., Casneuf, V. F., de Clerck, F., Looze, D. A. D., DeSchepper, H., Geboes, K. P., Hiele, M. I., Holvoet, T., Louis, H., et al. (2025) · Acta gastro-enterologica belgica · doi:10.51821/88.1.13772 · Cited by 1
Self-citation
Decoding the Gut Microbiota: Mechanisms of Host-Microbe Interactions and Inflammatory Pathologies
Richie, T. G., & Lee, S. T. M. (2025) · Digestion · doi:10.1159/000549457 · Cited by 1
Fecal microbiota transplantation from different pig breeds alters fat deposition and gut microbiota in mice
Yang, F., Liu, S., Liu, G., Luo, L., Lu, X., Lin, W., Chen, J., & Lin, R. (2026) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-026-13823-z · Cited by 1
Fermented millets as next-generation functional foods: insights into microbiota modulation and gastrointestinal health
Kumar, V., Sharma, C., Bhatt, S. C., Rajput, V., Mishra, R., Gupta, A. K., Shikha, D., Kumar, V., & Naik, B. (2026) · Food Production Processing and Nutrition · doi:10.1186/s43014-026-00402-y · Cited by 1
“Interventional studies have reported improved digestive health attributes, such as a reduction in abdominal distension and enhanced bowel motility (Holvoet et al., 2021).”
Therapeutic Response Prediction of Fecal Microbiota Transplantation for Patients with Irritable Bowel Syndrome: In Terms of Gut Microbiota
Kim, D. S. (2022) · Korean Journal of Gastroenterology · doi:10.4166/kjg.2022.126 · Cited by 1
Beneficial metabolic effects of PAHSAs depend on the gut microbiota in diet-induced obese micePreprint
Lee, J., Wellenstein, K., Rahnavard, A., Nelson, A. T., Holter, M. M., Cummings, B. P., Yeliseyev, V., Castoldi, Â., Clish, C. B., Bry, L., et al. (2023) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2023.09.28.558803 · Cited by 1
Fecal microbiome transplantation reverses obesity-induced neuropathic pain
Granados‐Soto, V. (2021) · Mexican Journal of Medical Research ICSA · doi:10.29057/mjmr.v9i17.6696
Characteristics of Gut Microbiota in Diarrhea-predominant Irritable Bowel Syndrome of Han Nationality in Southwest ChinaPreprint
Yao, C., Li, Y., Luo, L., Xie, F., Xiong, Q., Li, T., Yang, C., & Feng, P. (2021) · Research Square · doi:10.21203/rs.3.rs-871688/v1
Irritable bowel syndrome and transplantation of fecal microbiota. Review
Fadieienko, G. D., & Gridnyev, O. (2021) · Modern Gastroenterology · doi:10.30978/mg-2021-4-45
调查显示：很多大学生存在人际交往障碍，专家提示——学会沟通尊重他人
刘京京 (2008) · 中外健康文摘
Hypnotherapy and IBS: Implicit and Simple Stress Memory in ENS?Preprint
Császár, N., & Bókkon, I. (2022) · SSRN Electronic Journal · doi:10.2139/ssrn.4148409
Progress in application of probiotics, prebiotics, and synbiotics in irritable bowel syndrome
Zhu, L., Huang, B.-W., Zhang, X., & Ning, Z. H. (2022) · World Chinese Journal of Digestology · doi:10.11569/wcjd.v30.i8.375
Gut microbiota modulates distal symmetric polyneuropathy in diabetic patientsPreprint
Yang, J., Yang, X., Wu, G. G., Huang, F., Shi, X., Wei, W., Zhang, Y., Zhang, H., Cheng, L., Yu, L., et al. (2022) · medRxiv · doi:10.1101/2022.10.07.22280806
Current Status and Efficacy of Fecal Microbiota Transplantation for Patients Suffering from Irritable Bowel Syndrome
Arbab, M. H. (2023) · Wiley eBooks · doi:10.1002/9781119904786.ch20
Editorial: Faecal microbiota transplantation in IBS —Moving closer or away from success? Authors' reply
Su, Q., Yau, Y. K., & Ng, S. C. (2023) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17729
“6 Although the long-term effect of a single FMT treatment disappeared rather quickly in the majority of patients, in that only 21% of successfully treated patients had a beneficial effect lasting longer than 1 year, re-transplantation was shown to salvage the effect in 67% of patients, suggesting…”
BackgroundResult
Letter: A step forward towards a standard FMT protocol for IBS
El‐Salhy, M., Gilja, O. H., & Hatlebakk, J. G. (2023) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17749
Fecal microbiota transplantation for treatment of irritable bowel syndrome: Current advances and future perspectives
Liu, X., & Wu, S. (2023) · World Chinese Journal of Digestology · doi:10.11569/wcjd.v31.i22.922
Das intestinale Mikrobiom bei gastroenterologischen Krankheitsbildern
Reindl, W. (2023) · Gastroenterologie up2date · doi:10.1055/a-1824-0120
Fecal Microbiota Transplantation
Singh, B., Mal, G., Kalra, R. S., & Marotta, F. (2024) · Springer eBooks · doi:10.1007/978-3-031-65459-6_36
TRANSPLANTE DE MICROBIOTA FECAL NO TRATAMENTO DA SÍNDROME DO INTESTINO IRRITÁVEL: UMA REVISÃO DE ESCOPO
de Menezes, R. V., Lapenda, J. F. D. P. P., Knopp, A. G., Ferreira, M. S., Campos, F. L. B. O., Costa, M., Crusco, G. S., Ferreira, A. L. M. M., & Silva, H. R. D. S. E. (2025) · Brazilian Medical Students · doi:10.53843/bms.v10i14.742
A Refractory, Gas-Predominant Subgroup of Irritable Bowel Syndrome Markedly Improved With Relatively Long-Term Paroxetine Treatment: A Preliminary Study
Mine, K., Murata, Y., Fujino, M., Fujino, T., & Enjoji, M. (2025) · Cureus · doi:10.7759/cureus.85494
“To date, a small number of studies have reported on a subgroup of IBS for which the most bothersome symptom is intestinal-gas [3,7,8].”
Linking Gut Microbiota and Irritable Bowel Syndrome (Ibs): A Review
Karasek, M., Szyszko, M., Polański, K., Andrzejczuk, S., Kasela, M., & Kosikowska, U. (2025) · Postępy Mikrobiologii - Advancements of Microbiology · doi:10.2478/am-2025-0012 · Cited by 1
Additional file 1 of Fecal microbiota transplantation in the treatment of irritable bowel syndrome: a single-center prospective study in Japan
Hamazaki, M., Sawada, T., Yamamura, T., Maeda, K., Mizutani, Y., Ishikawa, E., Furune, S., Yamamoto, K., Ishikawa, T., Kakushima, N., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20317520
Additional file 3 of Clinical efficacy and safety of faecal microbiota transplantation in the treatment of irritable bowel syndrome: a systematic review, meta-analysis and trial sequential analysis
Lo, S.-W., Hung, T.-H., Lin, Y.-T., Lee, C.-S., Chen, C.-Y., Fang, C.-J., & Lai, P.-C. (2024) · Figshare · doi:10.6084/m9.figshare.27049199
Additional file 3 of Fecal microbiota transplantation in the treatment of irritable bowel syndrome: a single-center prospective study in Japan
Hamazaki, M., Sawada, T., Yamamura, T., Maeda, K., Mizutani, Y., Ishikawa, E., Furune, S., Yamamoto, K., Ishikawa, T., Kakushima, N., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20317526
Additional file 5 of Fecal microbiota transplantation in the treatment of irritable bowel syndrome: a single-center prospective study in Japan
Hamazaki, M., Sawada, T., Yamamura, T., Maeda, K., Mizutani, Y., Ishikawa, E., Furune, S., Yamamoto, K., Ishikawa, T., Kakushima, N., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20317532
Additional file 1 of Clinical efficacy and safety of faecal microbiota transplantation in the treatment of irritable bowel syndrome: a systematic review, meta-analysis and trial sequential analysis
Lo, S.-W., Hung, T.-H., Lin, Y.-T., Lee, C.-S., Chen, C.-Y., Fang, C.-J., & Lai, P.-C. (2024) · Figshare · doi:10.6084/m9.figshare.27049190
Additional file 5 of Clinical efficacy and safety of faecal microbiota transplantation in the treatment of irritable bowel syndrome: a systematic review, meta-analysis and trial sequential analysis
Lo, S.-W., Hung, T.-H., Lin, Y.-T., Lee, C.-S., Chen, C.-Y., Fang, C.-J., & Lai, P.-C. (2024) · Figshare · doi:10.6084/m9.figshare.27049205
Additional file 1 of A meta-analysis of randomized controlled trials evaluating the effectiveness of fecal microbiota transplantation for patients with irritable bowel syndrome
Wang, Y., Hu, Y., & Shi, P. (2024) · Figshare · doi:10.6084/m9.figshare.26743745
Additional file 2 of Clinical efficacy and safety of faecal microbiota transplantation in the treatment of irritable bowel syndrome: a systematic review, meta-analysis and trial sequential analysis
Lo, S.-W., Hung, T.-H., Lin, Y.-T., Lee, C.-S., Chen, C.-Y., Fang, C.-J., & Lai, P.-C. (2024) · Figshare · doi:10.6084/m9.figshare.27049196
Additional file 2 of Fecal microbiota transplantation in the treatment of irritable bowel syndrome: a single-center prospective study in Japan
Hamazaki, M., Sawada, T., Yamamura, T., Maeda, K., Mizutani, Y., Ishikawa, E., Furune, S., Yamamoto, K., Ishikawa, T., Kakushima, N., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20317523
Additional file 4 of Fecal microbiota transplantation in the treatment of irritable bowel syndrome: a single-center prospective study in Japan
Hamazaki, M., Sawada, T., Yamamura, T., Maeda, K., Mizutani, Y., Ishikawa, E., Furune, S., Yamamoto, K., Ishikawa, T., Kakushima, N., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20317529
Additional file 4 of Clinical efficacy and safety of faecal microbiota transplantation in the treatment of irritable bowel syndrome: a systematic review, meta-analysis and trial sequential analysis
Lo, S.-W., Hung, T.-H., Lin, Y.-T., Lee, C.-S., Chen, C.-Y., Fang, C.-J., & Lai, P.-C. (2024) · Figshare · doi:10.6084/m9.figshare.27049202
Fecal microbiota transplantation for indolent T-cell lymphoproliferative disorder of gastrointestinal tract: A case report and review of literature
Yu, Y., Huang, J., Chen, Y., & Lu, B.-Y. (2026) · World Journal of Gastrointestinal Endoscopy · doi:10.4253/wjge.v18.i4.115366
Protocol for a pilot feasibility randomised controlled trial of fecal microbiota transplantation for adolescent anorexia nervosa
Couturier, J. L., Kenner, E., Nicula, M., Chowdhury, F., Surette, M., & Pai, N. (2026) · BMJ Open · doi:10.1136/bmjopen-2025-109115
“During informed consent (see online supplemental material file for the participant consent form), the RA will explain that participants have a right to withdraw from the study at any time without negative consequences, including any impact on the standard treatment they are receiving.”
Seven years of stool banking: Clinical and microbiological insights from the Ghent Stool Bank
Hamerlinck, H., Boelens, J., Looze, D. A. D., Messiaen, A.-S., Vandendriessche, S., Holvoet, T., & Verhasselt, B. (2026) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2026.108744
Self-citation
Feasibility and efficacy of fecal microbiota transplantation in adolescents with refractory irritable bowel syndrome: A randomized clinical pilot trial
de Bruijn, C. M. A., Oorthuys, A. O. J., Zeevenhooven, J., Davids, M., Levels, J. H. M., Vlieger, A. M., Herrema, H., Nieuwdorp, M., & Benninga, M. A. (2026) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1002/jpn3.70459
“In adult IBS patients, some studies performed FMT by using a mix of healthy donor stool, 25,28 whereas others used two to four different donors, 23,26,27 or one single donor for all FMTs. 24,29 This variability could explain con ﬂ icting study results.”
Cross-kingdom microbial associations characterize responsiveness to fecal microbiota transplantation in patients with irritable bowel syndrome
Yan, Q., Li, M., Wang, G., Zhang, A., Li, Y., Guo, R., Zhang, Y., Yang, W., Zhang, Y., Liu, X., et al. (2026) · Journal of Translational Medicine · doi:10.1186/s12967-026-08269-w
Bioinformatic identification of CD8+ T cell activation mediated by key genes in fecal microbiota transplantation for irritable bowel syndrome
Fei, Y., Gao, M.-Y., Qiao, N., Hu, J., He, L., Jiao-li, Z., Zheng, N.-N., & Liu, T.-T. (2026) · PLoS ONE · doi:10.1371/journal.pone.0351574
“Fecal microbiota transplantation (FMT) has emerged as a promising strategy for treating IBS [5,6].”
Microbiota-gut-brain axis and abdominal pain: Disorders of gut-brain interaction and microbiome-based therapeutic strategies
Łoniewski, I., Skonieczna‐Żydecka, K., & Marlicz, W. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-41638-5.00014-4
Eje microbiota-intestino-cerebro en el síndrome del intestino irritable: mecanismos fisiopatológicos y perspectivas terapéuticas
Fernandez, W. D., Vargas, V. P. S., Padilla-Zambrano, H., Cerino-Peñaloza, M. S., Saldaña-Ruiz, M. A., & Leggett, C. L. (2026) · Revista de Gastroenterología del Perú · doi:10.47892/rgp.2026.462.2230

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: Holvoet, Tom
Joossens, Marie
Vázquez-Castellanos, Jorge F.
Heyerick, Lander
Boelens, Jerina
Verhasselt, Bruno
Raes, Jeroen
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2021-01
Volume: 160
Issue: 1
Pages: 145-157.e8
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2020.07.013
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
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
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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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

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