Background: Severity in irritable bowel syndrome (IBS) is associated to impaired quality of life and fatigue. Fecal microbiota transplantation (FMT) induces significant relief in gastro-intestinal related complaints. The objective was to evaluate the effect of FMT on the secondary endpoints: IBS-related quality of life and fatigue in patients with non-constipated IBS. Method: In this double-blind randomized placebo-controlled, parallel-group, single-center study, we enrolled patients with non-constipated IBS, defined by the ROME 3 criteria. We randomly assigned participants (2:1) in blocks of six to active or placebo FMT. Responder in fatigue and quality of life were defined as a decrease of 20 points in total Fatigue Impact Scale score, and improvement of 14 points in the IBS-quality of life questionnaire, respectively. In a modified-intention-to-treat population, we excluded participants who did not undergo treatment or who were diagnosed with any other disease by pinch biopsies during the treatment procedure. Findings: Between Jan1, and Oct 30, 2015, we recruited 90 participants and randomly assigned them to active treatment (n = 60) or placebo (n = 30). Three participants did not undergo FMT and four were excluded after diagnosis of microscopic colitis, leaving 83 for final modified intention-to-treat analysis (55 in the active treatment group and 28 in the placebo group). Significant improvement in QoL (Odds ratio (OR) 3,801; confidence interval (CI) = 1,309À11,042 p = 0.011) and fatigue (OR = 4,398; CI = 1,175À16,468 and p = 0,020) was found at six months. Absence of other self reported functional disorders and presence of depression at baseline is suggested to predict a lasting effect of FMT in QoL and fatigue, respectively. Interpretation: FMT induced significant relief in quality of life and fatigue. Results suggest a lasting effect of FMT in subgroups that should be further investigated in future studies. Funding Helse Nord, Norway and the
Irritable bowel syndrome (IBS) is a common disorder of the lower gastrointestinal tract. The pathophysiology is far from settled, but a gut microbial dysbiosis is hypothesized to be a contributing factor. We earlier published a randomized double-blind placebo-controlled clinical trial on fecal microbiota transplantation (FMT) for IBS – the REFIT trial. The present data set describes the engraftment and includes participants from the study who received active FMT; 14 participants with effect of FMT ( Effect ) and 8 without ( No effect ). Samples were collected at baseline, after 6 and 12 months. Samples from the transplants ( Donor ) served as a comparator. In total 66 recipient samples and 17 donor samples were subjected to deep metagenomic sequencing, and taxonomic and functional analyses were performed. Alpha diversity measures showed a significantly increased diversity and evenness in the IBS groups compared to the donors. Taxonomic profiles showed higher relative abundance of phylum Firmicutes, and lower relative abundance of phylum Bacteroidetes, compared to donors at baseline. This profile was shifted toward the donor profile following FMT. Imputed growth rates showed that the resulting growth pattern was a conglomerate of donor and recipient activity. Thirty-four functional subclasses showed distinct differences between baseline samples and donors, most of which were shifted toward a donor-like profile after FMT. All of these changes were less pronounced in the No effect group. We conclude that FMT induces long-term changes in gut microbiota, and these changes mirror the clinical effect of the treatment. The study was registered in ClinicalTrials.gov (NCT02154867).
When long-lasting, unresolved diarrhoeic conditions are present in patients over 45-50 years of age, colonoscopy with biopsy should be performed to rule out MC and other pathologies before diagnosing IBS. In younger patients with pronounced watery diarrhoea, one should consider colonoscopy individually if there is no response to IBS-treatment.
De siste månedene har det pågått en spennende debatt omkring behandling av kronisk utmattelse.Myalgisk encefalopati/kronisk utmattelsessyndrom (ME/CFS) har vaert heftig debattert siden Egeland og medarbeideres kronikk sto på trykk i Tidsskriftet nr. 19/2015 (1).Jeg ønsker å komme med et innspill. Jeg var selv i en slags langvarig utmattelsestilstand i årene 2013 -14. Hos meg hadde prednisolon 30 mg en frapperende effekt på symptomene. Derfor bestemte jeg meg for å søke etter studier der man har undersøkt effekten av prednisolon/kortison på kronisk utmattelse og myalgisk encefalopati. Tre studierEtter søk i to forskjellige databaser (PubMed, Cochrane library) med søkeordene «hydro-cortisone», «prednisolone» og «myalgic encephalomylitis/chronic fatigue syndrome» fant jeg to artikler -av McKenzie og medarbeidere (2) og Blockmans og medarbeidere Jeg fant også en tredje studie der man undersøkte effekten av lavdose kortison versus placebo. Cleare og medarbeidere behandlet 32 pasienter med 5 -10 mg hydrokortison i fire uker i en kryssundersøkelse (4). Hydrokortison ga statistisk signifikant bedre utfall enn placebo. Forfatterne oppfordret til oppfølgingsstudier for å finne ut om lavdose hydrokortisonbehandling kan vaere nyttig ved kronisk utmattelsessyndrom.I den norske fagdebatten skrev Vegard Bruun Wyller og medarbeidere (5) at kortison ikke har vist seg effektivt. Som referanse brukte han en oversiktsartikkel av Smith og medarbeidere (6), som igjen refererer til McKenzie og medarbeidere (2) og Blockmans og medarbeidere (3). Smith og medarbeideres artikkel bygger på systematiske søk i forskjellige databaser, som resulterte i 6 175 identifiserte abstrakter, 35 behandlingsstudier og 45 artikler. I kun ni studier ble effekter av medikamentell behandling undersøkt. To av disse var de ovennevnte studiene der lavdose hydrokortison ble anvendt (2, 3). Konklusjonen i Smith og medarbeideres artikkel var at medikamentell behandling ikke hadde positiv effekt, men at studiepopulasjonen var for liten.I Kunnskapssenterets anbefalinger fra 2008 om behandling av myalgisk encefalopati/kronisk utmattelsessyndrom omtales kort at medikamentell behandling med kortison er forsøkt, uten å gi nevneverdig effekt (7). Igjen brukes to av de ovennevnte artiklene som referanser (3, 4).I en omtale om kronisk tretthetssyndrom av Erlend Hem i Tidsskriftet fra 2001 skriver han at kognitiv terapi og moderat trening synes å ha best effekt på kronisk utmattelse (8). Det nevnes dessuten at behandling med lavdose hydrokortison har positiv effekt på kronisk tretthetssyndrom. Referansen Hem brukte, var en artikkel av Whiting og medarbeidere (9). Konklusjonen i denne var at lavdose hydrokortison synes å ha effekt, men resultatene vurderes som inkonklusive grunnet få studier. Whiting og medarbeidere brukte studiene til McKenzie og medarbeidere (2) og Cleare og medarbeidere (4) som bakgrunn for sin konklusjon, mens Smith og medarbeidere bygde sine konklusjoner på studiene til McKenzie og medarbeidere (2) og Blockmans og medarbeidere (3). I perioden 2001 -15...
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