Multidonor FMT capsules improve symptoms and decrease fecal calprotectin in ulcerative colitis patients while treated – an open-label pilot study

Cold, Frederik; Browne, Patrick; Günther, Stig; Halkjær, Sofie Ingdam; Al-Gibouri, Z; Hansen, Lasse; Christensen, Alice Højer

doi:10.1080/00365521.2019.1585939

Cited by 39 publications

(50 citation statements)

References 29 publications

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“…The present study demonstrated that three rounds of FMT (13,(28)(29)(30). The improved efficacy displayed in the present study may be explained by the modified FMT procedures used, including stool preparation (feces exposure to air for <30 min), microbiota resource (fresh; all FMTs for one patient were derived from the same donor), delivery route (via TET tube; remained in the right lateral position for 30 min to maintain the largest contact area between microbiota and intestines), dosage (150 ml to avoid inducing intestinal peristalsis) and intensity (three times within one week).…”

Section: Discussionsupporting

confidence: 59%

“…A number of systematic reviews have reported various approaches of FMT for the treatment of IBD, including colonoscopy, retention enema, nasoduodenal tube, pills or a combination (43,44). Paramsothy et al (15) used the retention enema approach to perform FMT in patients with UC, while Gordon et al (11) employed a nasoduodenal tube approach, and Cold et al (28) investigated the use of FMT capsules. According to two retrospective studies (45,46), nasointestinal delivery can be uncomfortable and result in a number of AEs, including severe nausea, vomiting, reduced food intake and sensory discomfort; delivery of the fecal microbiota suspension to the cecum may be difficult with the retention enema method; furthermore, the FMT capsule preparation increases the exposure time of the microbiota to the air, thus affecting bacterial activity.…”

Section: Discussionmentioning

confidence: 99%

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Fecal microbiota transplantation ameliorates active ulcerative colitis

Chen

Huang

et al. 2020

Exp Ther Med

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Ulcerative colitis (UC) is a complex chronic pathological condition of the gut in which microbiota targeted treatment, such as fecal microbiota transplantation (FMT), has shown an encouraging effect. The aim of the present study was to investigate the efficacy and safety of FMT in patients with mild or moderate UC. A single-center, open-label study was designed, including 47 patients with mild or moderate active UC who received three treatments of fresh FMT via colonic transendoscopic enteral tubing within 1 week. The inflammatory bowel disease questionnaire, partial Mayo scores, colonoscopy, erythrocyte sedimentation rate, C-reactive protein level and procalcitoin values were used to assess the efficacy of FMT and alteration in gut microbiota was detected by 16S ribosomal RNA-sequencing. Before FMT, microbiota Faecalibacterium prausnitzii (F. prausnitzii) levels were significantly decreased in patients with UC compared with healthy donors (P<0.01). At 4 weeks post-FMT, F. prausnitzii levels were significantly increased (P<0.05), and the Mayo score was significantly decreased (1.91±1.07 at baseline vs. 4.02±1.47 at week 4; P<0.001) in patients with UC compared with healthy donors. Steroid-free clinical responses were reported in 37 patients (84.1%), and steroid-free clinical remission was achieved in 31 patients (70.5%) at week 4 post-FMT, however, steroid-free remission was not achieved in any patient. No adverse events were reported in 41 (93.2%) patients after FMT or during the 12-week follow-up. Shannon's diversity index and Chao1 estimator were also improved in patients with UC receiving FMT. In conclusion, the results of the present study suggested that FMT resulted in clinical remission in patients with mild to moderate UC, and that the remission may be associated with significant alterations to the intestinal microbiota of patients with UC. Furthermore, F. prausnitzii may serve as a diagnostic and therapeutic biomarker for the use of FMT in UC.

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Section: Discussionsupporting

confidence: 59%

Section: Discussionmentioning

confidence: 99%

Fecal microbiota transplantation ameliorates active ulcerative colitis

Chen

Huang

et al. 2020

Exp Ther Med

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“…The stool type subgroup analysis revealed clinical remission rates of 29.1% for fresh fecal material [17-20, 22-26, 28-32, 35, 38, 42, 46, 47, 51, 52], 44.2% for frozen fecal material [21,27,39,45,49,50], 57.2% when both types of stool were used [36,48,53], and 66.5% for capsules [37,43], with a statistical difference observed among the groups (p = 0.036). Two articles did not report the type of stool used for the FMT [33,34] (Table 2, S4 Fig).…”

Section: Proportions Meta-analysesmentioning

confidence: 99%

Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis

et al. 2020

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Objectives Current evidence on fecal microbiota transplantation for inflammatory bowel disease is inconclusive. We conducted a systematic review to gather evidence on the efficacy and safety of fecal microbiota transplantation for inflammatory bowel disease. Methods Systematic searches were conducted in PubMed, Scopus, and Web of Science. Clinical remission was considered as the primary endpoint. Pairwise meta-analyses were performed for the randomized controlled studies (Mantel Haenszel, random effects model). Proportion meta-analyses, accounting for weighted pooled rates reported in the interventional studies, were conducted using the mixed effects model. Subgroup analyses considering the type of stool, donor type, and disease subtype were also performed. Cumulative meta-analyses to assess further needs of evidence were conducted. Results Sixty studies were included, from which 36 could be synthesized in the quantitative analyses. Pairwise meta-analyses of six controlled trials showed significant differences in favor of fecal microbiota transplantation compared with placebo (clinical remission: RR 1.70 [95% CI 1.12, 2.56]; clinical response: RR 1.68 [95% CI 1.04, 2.72]). An overall clinical remission of 37%, overall clinical response of 54%, and a prevalence of 29% of adverse events were found for the interventional studies. Frozen fecal material and universal donors were related to better efficacy outcomes. In addition, Crohn's disease patients seemed to benefit more from the procedure. Conclusions The comparative analyses demonstrated that frozen fecal material from universal donors may be related to a higher rate of clinical remission, especially for Crohn's disease.

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“…In prior studies using serial endoscopic or enema-based regimens, persistent microbiota changes have been detected for up to 16 weeks in UC patients [11][12][13][14]. The only report to our knowledge of microbial changes following oral FMT monotherapy in UC patients showed no differences in alpha diversity nor evidence of donor convergence [24], raising the possibility that large volume FMT induction may be necessary to achieve initial community-level donor convergence.…”

Section: Discussionmentioning

confidence: 92%

“…Prior randomized control trials, involving multiple enemas and/or colonoscopy-based administrations have shown early clinical impact from FMT in UC populations [11][12][13][14]. Only one other study is known to us in which daily cFMT was trialed in the treatment of UC [24]. In it, 7 subjects took 25 frozen FMT capsules daily (~ 12 g of fecal matter) for 50 days in an open label trial design.…”

Section: Discussionmentioning

confidence: 99%

Daily, Oral FMT for Long-Term Maintenance Therapy in Ulcerative Colitis: Results of a Single-Center, Prospective, Randomized Pilot Study.

Crothers

Nguyen

Phillips

et al. 2020

Preprint

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This randomized study was designed to assess the safety and feasibility of long-term fecal microbiota transplantation (FMT) in subjects with mild to moderate UC using frozen, encapsulated oral FMT (cFMT). FMT induction was implemented by colonoscopy, followed by 12 weeks of daily oral administration of frozen encapsulated cFMT. Ribosomal 16S bacterial sequencing was used to assess donor-induced changes in the gut microbiota. Changes in T regulatory (Treg) and mucosal associated invariant T (MAIT) cell populations were evaluated as an exploratory endpoint. Twelve subjects with active UC were randomized: 6 subjects completed the full 12-week course of FMT plus cFMT, and 6 subjects received sham treatment by colonic installation and longitudinal oral treatment. Chronic administration of cFMT was found to be safe and well-tolerated. Protocol adherence was high, and none of the study subjects experienced FMT-associated treatment emergent adverse events. While n-values were too small to draw firm conclusions, 3/6 subjects that received cFMT exhibited multiple signs of clinical improvement. These pilot data suggest that daily encapsulated cFMT may extend the durability of index FMT-induced changes in gut bacterial community structure and that an association between MAIT cell cytokine production and clinical response to FMT may exist in UC populations. Oral frozen encapsulated cFMT is a promising FMT delivery system and may be preferred for longterm treatment strategies in UC and other chronic diseases but further evaluations will have to address home storage concerns. Larger trials should be done to explore the benefits of cFMT and to determine its long-term impacts on the colonic microbiome. Trial registration: ClinicalTrials.gov (NCT02390726). Registered 17 March 2015, https://clinicaltrials.gov/ct2/show/NCT02390726?term=NCT02390726&draw=2&rank=1.

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Multidonor FMT capsules improve symptoms and decrease fecal calprotectin in ulcerative colitis patients while treated – an open-label pilot study

Cited by 39 publications

References 29 publications

Fecal microbiota transplantation ameliorates active ulcerative colitis

Fecal microbiota transplantation ameliorates active ulcerative colitis

Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis

Daily, Oral FMT for Long-Term Maintenance Therapy in Ulcerative Colitis: Results of a Single-Center, Prospective, Randomized Pilot Study.

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