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

NCT05088434 | Completed

• 1 other identifier: 2016/1914
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Irritable Bowel Syndrome; Dysbiosis

Keywords

IBS; Fecal microbiota transplantation; ACHIM; Placebo; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Gut microbiota analysis

  Change in bacterial signals from baseline before transplantation with either donor-FMT, ACHIM of placebo to after transplantation at weeks 1, 4, 12 and 24, by using the GA-map Dysbiosis Test (Genetic Analysis AS, Oslo, Norway). The GA-test is based comprising fecal sample homogenization and mechanical bacterial cell disruption; combined with chemical cell lysis; automated total bacterial genomic DNA extraction using magnetic beads; 16S rRNA PCR DNA amplification covering the variable regions V3-V9; probe labelling by single nucleotide extension; hybridisation to complementary probes coupled to magnetic beads; and signal detection using BioCode 1000A 128-Plex Analyzer (Applied BioCode, Santa Fe Springs, California, USA). A Dysbiosis Index (DI) above 2 (maximum 5) indicated microbiota that differs from the reference group (DI 1-2: non-dysbiosis, DI 3: moderate, DI 4-5: severe dysbiosis).

  6 months

Secondary Outcomes (5)

• Irritable bowel syndrome Symptom Severity Scale (IBS-SSS)

  6 months

• Bristol stool form scale

  6 months

• Short form of Nepean Dyspepsia Index (SF-NDI)

  6 months

• Eysenck Personality Questionnaire Neuroticism (EPQ-N-12_

  6 months

• Hospital Anxiety and Depression Scale (HADS)

  6 months

Study Arms (3)

donor FMT

ACTIVE COMPARATOR

Fresh stool samples were obtained immediately from close family member (donor) before being re-transplanted into the patient through a gastroscope.

Dietary Supplement: Donor fecal microbiota transplantation

ACHIM

ACTIVE COMPARATOR

One vial of ACHIM suspension (ACHIM Biotherapeutics AB, 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: Anaerobically Cultivated Human Intestinal Microbiota (ACHIM)

Placebo

PLACEBO COMPARATOR

Fresh stool samples were obtained from the patients themselves immediately before transplantation and re-transplanted through a gastroscope.

Dietary Supplement: Placebo

Interventions

Anaerobically Cultivated Human Intestinal Microbiota (ACHIM) DIETARY_SUPPLEMENT

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.

ACHIM

Donor fecal microbiota transplantation DIETARY_SUPPLEMENT

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.

donor FMT

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age between 18-and 65 years.
• Have IBS-Symptom Severity Scale (IBS-SSS) score \>175.
• All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or mixed constipation and diarrhoea (IBS-M) with bloating or flatulence as predominant symptoms.
• All patients will undergo appropriate investigations to exclude organic disease.

You may not qualify if:

• History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool
• Antibiotic use within 1 month prior to FMT
• Immunocompromised patient defined as taking immuno-suppressive medications
• History of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
• Patients who are scheduled for abdominal surgery.
• Pregnant or lactating women.
• Patients taking probiotics or taking antibiotics within 4 weeks prior to installation.
• Close healthy, family members
• \> 18 years old.
• Pregnancy or lactation
• History of inflammatory bowel diseases, IBS, chronic abdominal pain, or gastrointestinal malignancy, diarrhea, blood in stool
• Antibiotic and pre/probiotic use within 1 month prior to FMT.
• Immunocompromised defined as taking immuno-suppressive medications
• History of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland Unversity Hospital

Bergen, 5120, Norway

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dysbiosis

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Trygve Hausken, M.D, Ph.D

  Haukeland University Hospital

  STUDY CHAIR

• Tarek Mazzawi, M.D, Ph.D

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded placebo-controlled study

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 22, 2021
• Study Start: January 1, 2017
• Primary Completion: August 30, 2020
• Study Completion: June 30, 2021
• Last Updated: February 29, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)