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Fecal Microbiota Transplantation and ACHIM for Manipulating Gut Microbiota in IBS Patients

NCT05088434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-02-29

No results posted yet for this study

Summary

The double-blinded placebo-controlled study compares the effect of fecal microbiota transplantation vs. Anaerobically Cultivated Human Intestinal Microbiota (ACHIM) or placebo (own feces) on manipulating the gut microbiota in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Conditions

Interventions

DIETARY_SUPPLEMENT

Anaerobically Cultivated Human Intestinal Microbiota (ACHIM)

One vial of ACHIM suspension (ACHIM Biotherapeutics AB, Vallingby, Sweden), containing 30 x 109 colony forming unit (CFU) of bacteria, was given through the work channel of a gastroscope into the lower part of duodenum.

DIETARY_SUPPLEMENT

Donor fecal microbiota transplantation

Only 60 ml of sterile 0.9% normal saline were added to a stool specimen, collected from the respective donor, with a weight of \~30 g and homogenized manually. Then 60 ml of feces-suspension (screened from the patients view) were instilled through the work channel of a gastroscope into the lower part of the duodenum.

DIETARY_SUPPLEMENT

Placebo

Only 60 ml of sterile 0.9% normal saline were added to the patient's own stool specimen with a weight of \~30 g and homogenized manually. Then 60 ml of feces-suspension (screened from the patients view) were instilled through the work channel of a gastroscope into the lower part of the duodenum.

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Trygve Hausken, M.D, Ph.D · Haukeland University Hospital

  • Tarek Mazzawi, M.D, Ph.D · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-08-30
Completion
2021-06-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088434 on ClinicalTrials.gov