Michael Harrop
Well-known member
https://journals.sagepub.com/doi/10.1177/17562848261452497
A group from Denmark.
A group from Denmark.
Abstract
Background:
During surgical treatment for ulcerative colitis, an ileal pouch-anal anastomosis is often constructed. Pouchitis, the most common complication after this surgery, substantially reduces patients’ quality of life (QoL). In chronic pouchitis, antibiotic treatment often proves ineffective. Fecal microbiota transplantation (FMT) has emerged as a potential treatment for chronic pouchitis.
Objectives:
To determine the effect of FMT on QoL in patients with chronic pouchitis.
Design:
An exploratory post hoc analysis of data from the MicroPouch trial. A double-blinded, placebo-controlled study comprising a 4-week intervention period and 12-month follow-up.
Method:
Thirty patients with chronic pouchitis were randomized 1:1 to receive either FMT or placebo. Treatment was administered by enema once daily for 2 weeks, then every other day for the following 2 weeks. QoL was assessed using three questionnaires—the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), the Pouch Dysfunction Score (PDS), and the 36-item Short Form Questionnaire (SF-36)—at baseline and at subsequent follow-ups.
Results:
At the 30-day follow-up, FMT-treated patients showed a significant decrease in QoL from baseline, measured by the SIBDQ (p = 0.03). Within the FMT group, the PDS did not change significantly from baseline to day 30 (p = 0.36). The placebo group reported higher SF-36 QoL scores at both baseline and day 30 (p = 0.02), although neither group showed significant within-group changes over time.
Conclusion:
In patients with chronic pouchitis, FMT may temporarily worsen symptoms and reduce QoL, as indicated by three QoL questionnaires showing no improvement or poorer outcomes versus placebo.
Ridiculous donor criteria. The fact that they passed 13 of them highlights that. It should be no surprise that they made patients worse.Fecal donors were recruited at the Blood Bank at Aalborg University Hospital. Exclusion criteria included the following: any bowel system disease, previous bowel surgery, abnormal stool frequency (>2 per day), and use of prescribed or natural medicines. The donors were thoroughly screened with a blood test and fecal test for any transmissible diseases (bacterial or viral). No specific microbial composition was required. See the MicroPouch study for further information. Thirteen healthy donors were approved for fecal donation.
Enemas were chosen as the route of administration, as they can be self-administered at home and are less invasive than colonoscopy or gastroscopy, thereby minimizing the risk of serious adverse events.
Twenty-six patients answered the QoL questionnaires at the 30-day follow-up and went pouchoscopy performed. Ten patients answered the QoL questionnaires at the 6-month follow-up, and seven patients returned the questionnaires at the 12-month follow-up.
QoL questionnaire differences were no longer significant at 6 or 12 months
patients with greater energy and resources may have been more likely to return questionnaires, thereby introducing bias
some patients discontinued participation due to relapse and the need for antibiotics
Adverse events occurred more frequently among FMT-treated patients (80% vs 60%; p = 0.02).14 The number of adverse events did not correlate with SIBDQ or PDS means (p = 0.36 and p = 0.69), while a trend toward lower SF-36 scores with more events was observed in the FMT group (p = 0.07). Adverse events were reported during the treatment period, including abdominal pain, fatigue, discomfort, diarrhea, fever, feeling bloated, and nausea.14 No adverse events were reported during the follow-up period. All were mild and self-limiting. No serious adverse events were reported during the trial.
Yet they didn't even try.A potential explanation for the lack of QoL improvement may lie in donor-recipient compatibility. Previous studies suggest that both donor- and recipient-specific factors influence FMT efficacy, and that optimal characteristics in both are required to achieve the best outcome. Unfortunately, these determinants have not yet been clearly identified.
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