The effect of faecal microbiota transplantation on abdominal pain, stool frequency, and stool form in patients with moderate-to-severe irritable bowel syndrome: results from a randomised, double-blind, placebo-controlled study

Madsen, Anders; Halkjær, Sofie Ingdam; Christensen, Alice Højer; Günther, Stig; Browne, Patrick; Kallemose, Thomas; Hansen, Lars Hestbjerg

doi:10.1080/00365521.2021.1915375

Cited by 21 publications

(20 citation statements)

References 23 publications

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“…Similarly, in the study by Halkjær et al, patients in the placebo group had more obvious symptom improvement than those treated with FMT via oral capsules, although increased microbial diversity was observed in the FMT group ( 16 ). They further analyzed the effect of oral FMT on abdominal pain, stool frequency, and stool form, but found no clinical beneficial effect ( 25 ). In their following study, they found long-term increased anaerobic bacteria in the FMT group, such as Faecalibacterium, Prevotella , and Bacteroides ( 26 ).…”

Section: Discussionmentioning

confidence: 99%

Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials

Zhao

Zhang

et al. 2022

Front. Nutr.

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Background:Gut microbiota has been identified as an imbalance in patients with irritable bowel syndrome (IBS). Fecal microbiota transplantation (FMT) is a novel method to restore microbiota and treat IBS patients.ObjectiveTo conduct a meta-analysis and estimate the efficacy and safety of FMT for the treatment of IBS patients with subgroup analyses to explore the most effective way of FMT for IBS.MethodsAll eligible studies were searched from PubMed, Embase, Web of Science, and the Cochrane Library through multiple search strategies. Data were extracted from studies comprising the following criteria: double-blind, randomized controlled trials (RCTs) that compared the efficacy of FMT with placebo for adult patients (≥18 years old) with IBS. A meta-analysis was performed to evaluate the summary relative risk (RR) and 95% confidence intervals (CIs).ResultsA total of seven RCTs comprising 489 subjects were eligible for this meta-analysis. Pooled data showed no significant improvement of global IBS symptoms in patients with FMT compared with placebo (RR = 1.34; 95% CI 0.75–2.41, p = 0.32). A significant heterogeneity was observed among the studies (I2 = 83%, p < 0.00001). There was no significant evidence of funnel plot asymmetry (Egger's test, p = 0.719; Begg's test, p = 1.000), indicating no existence of publication bias. Subgroup analyses revealed that FMT operated by invasive routes, including gastroscope, colonoscope, and nasojejunal tube, significantly improved global IBS symptoms (RR = 1.96; 95% CI 1.23–3.11, p = 0.004) with heterogeneity (I2 = 57%, p = 0.06) and an NNT of 3 (95% CI 2–14). However, FMT delivered via oral capsules showed a negative impact on patients with IBS (RR = 0.56; 95% CI 0.33–0.96, p = 0.03) with a low heterogeneity (I2 = 39%, p = 0.2) and an NNH of 3 (95% CI 2–37).ConclusionThe current evidence from RCTs with all routes of FMT does not show significant global improvement in patients with IBS. However, FMT operated by invasive routes significantly improved global IBS symptoms.

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Section: Discussionmentioning

confidence: 99%

Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials

Zhao

Zhang

et al. 2022

Front. Nutr.

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“…The long-term maintenance of symptom improvement, however, has seldom been a principal outcome in studies utilising single FMT treatments. Indeed, only two SATs [ 20 , 23 ] and four RCTs [ 25 , 26 , 30 , 55 ] have reported on the longevity of symptom improvements after FMT. Importantly, out of these six studies, two reported deteriorating response rate of up to 63% one year after FMT [ 20 , 26 ], two reported a range of 78%–88% of respondents achieving sustained long-term improvement one year after FMT [ 23 , 55 ] and the remaining two found no significant short-term improvements, thus limiting long-term efficacy assessment [ 25 , 30 ].…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, only two SATs [ 20 , 23 ] and four RCTs [ 25 , 26 , 30 , 55 ] have reported on the longevity of symptom improvements after FMT. Importantly, out of these six studies, two reported deteriorating response rate of up to 63% one year after FMT [ 20 , 26 ], two reported a range of 78%–88% of respondents achieving sustained long-term improvement one year after FMT [ 23 , 55 ] and the remaining two found no significant short-term improvements, thus limiting long-term efficacy assessment [ 25 , 30 ]. Two studies have also reported significant improvement in the short term and long term of IBS symptoms and changes to the gut microbiota [ 56 , 57 ].…”

Section: Discussionmentioning

confidence: 99%

“…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][25][26][27]. However, oral encapsulated forms have frequently displayed no significant differences [28][29][30], demonstrated in a recent metaanalysis [31]. Consequently, the burden of disease remains high in patients with IBS, highlighting the need for improvements in available therapeutic options.…”

Section: Introductionmentioning

confidence: 99%

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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

Gunaratne

Clancy

et al. 2022

Gastroenterology Research and Practice

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Background. The use of faecal microbiota transplantation (FMT) in irritable bowel syndrome (IBS) has frequently failed to induce long-term symptomatic improvement. The use of multiple FMT infusions is one proposed mechanism through which the efficacy of FMT can be amplified. Aims. To evaluate the safety and efficacy of a novel six-month FMT treatment protocol in IBS. Methods. Patients diagnosed with IBS confirmed by Rome IV Criteria were recruited for single-centre, single-arm, prospective clinical observational study. Participants received one colonoscopically delivered FMT followed by 36 rectal enemas across a six-month period. Validated abdominal symptoms and Short-Form (SF-36) Quality of Life (QOL) questionnaires were collected at baseline, week-12, week-24, and week-56, respectively. Wilcoxon matched-pairs signed-rank tests were conducted to compare differences in abdominal symptom and SF-36 QOL scores over the follow-up timepoints. Statistical significance was set at 5%. Results. Sixty participants diagnosed with IBS [IBS-constipation ( n = 27 ), IBS-diarrhoea ( n = 18 ), and IBS-mixed ( n = 15 )] received the six-month FMT treatment. IBS symptom severity reduction was achieved in up to 61% of respondents at week-12, 64% of respondents at week-24, and maintained in up to 75% of respondents at week-52. Long-term reduction in symptom severity was associated with an increase in QOL, achieved in up to 64% of respondents at week-52 when compared to baseline. Adverse events were experienced in 28% of participants, though they were both transient and mild in nature. Conclusions. Six-month sustained FMT appears to be both safe and effective in the short- and long-term alleviation of IBS associated symptoms as well as improving participant QOL.

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“…Conflicting reports of improved abdominal pain 124 or no effects on abdominal pain 125 evaluations has to some degree dampened enthusiasm for faecal microbial transplant. 54 A novel emerging area for IBS pain is that of 'neuromodulation', especially with regards to the central and autonomic nervous systems.…”

Section: Novel and Emerg Ing Ibs Pain Manag Ement Approache Smentioning

confidence: 99%

Review article: current and future treatment approaches for pain in IBS

Paine

2021

Aliment Pharmacol Ther

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SummaryBackgroundAbdominal pain is a core symptom of IBS and a primary driver of care seeking. Visceral hypersensitivity is a key pathophysiological mechanism and therapeutic target for pain in IBS, with components of peripheral and central sensitisation and psychological factors.AimTo review current and future treatment approaches specifically for the pain component of IBS.MethodsPubmed search terms included combinations of irritable bowel, pain, visceral hypersensitivity, novel, new, emerging, future and advances.ResultsEstablished non‐pharmacological treatments for IBS pain include the low FODMAP diet, probiotics and psychological interventions, especially hypnotherapy. Tricyclics remain the best evidenced pharmacological approach with GCC agonists, tenapanor, lubiprostone, eluxadoline and 5HT3 antagonists second line according to patient characteristics and availability. Less well‐evidenced current options include anti‐spasmodics, peppermint oil, SSRIs, SNRIs, alpha 2 delta ligands, melatonin and histamine antagonists. Patients are vulnerable to iatrogenesis and harmful approaches to be avoided include opioids and unwarranted surgical interventions. For severe pain, the concept of augmentation with combined gut‐brain neuromodulators and psychotherapy in a multi‐disciplinary setting is considered. A plethora of molecular targets and ligands are emerging from pre‐clinical studies, together with early clinical evidence for a range of pharmacological, dietary, neurostimulation and novel psychological treatment delivery methods which are reviewed. The history of such emerging approaches, however, merits both caution and optimism in equal measure.ConclusionsDespite good in‐roads and emerging options, the management of abdominal pain remains one of the biggest challenges and research priorities for patients with IBS.

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The effect of faecal microbiota transplantation on abdominal pain, stool frequency, and stool form in patients with moderate-to-severe irritable bowel syndrome: results from a randomised, double-blind, placebo-controlled study

Cited by 21 publications

References 23 publications

Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials

Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome: A Meta-Analysis of Randomized Controlled Trials

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

Review article: current and future treatment approaches for pain in IBS

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