Improving Gut Health: Using Faecal Microbiota Transplantation (FMT) to Treat Digestive and Mental Health in Functional Bowel Disorder(FBD) Patients

Gut-Brain-Microbiome interaction: modulation of the Gut Microbiome by Faecal Microbiota Transplantation (FMT) in patients of Functional Bowel Disorder with psychiatric comorbidity

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069390

Enrollment

120

Registered

2024-06-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K580- Irritable bowel syndrome with diarrhea

Interventions

Intervention1: Fecal microbiota transplantation (FMT) in patients with Functional Bowel Disorder (FBD) with psychiatric co-moribidity.: After obtaining written informed consent standard guidelines to

Eligibility

Inclusion criteria

Inclusion criteria: Adult Patients more than 18 years History of chronic gastrointestinal disorder Associated psychiatric co-morbidity

Exclusion criteria

Exclusion criteria: Patient with age less than 18 years or more than 70 years Current, active or past inflammatory bowel disease Refusal to give consent

Design outcomes

Primary

Measure	Time frame
1. Improvement of gut microbiota post FMT 2. Compare modulation of gut microbiota pre and post FMT by microbiome analysis. 3.Coparison of IBS-SSS, IBS-QOL and GSRS scores as well as PHQ9, BAI and MDQ scores to determine improvement.Timepoint: 1. At baseline and total 12 months post FMT	—

Secondary

Measure	Time frame
1. Whether FMT works in IBS-D patients with psychiatric co-morbidity or not. 2. Observation & interpretation on mode of FMT to the effect. 3.Evaluation of whether there is any difference in effects of allogenic & autogenic FMT. 4.Time duration the altered gut microbiota stays healthy within recipients gut. 5.Statistical analysis will be performed using SPSS 16.0Timepoint: 1. Blood & stool monitoring after 7 days. 2. Gut microbiome monitoring after 1 month, 3 months, 6 months & 12 months. 3. Mean score improvement of IBS-SSS, IBS-QOL & GSRS scale at 3 months, 6 months & 12 months. 4. Mean score improvement of BAI, PHQ9 & MDQ scales	—

Measure

Time frame

1. Whether FMT works in IBS-D patients with psychiatric co-morbidity or not. 2. Observation & interpretation on mode of FMT to the effect. 3.Evaluation of whether there is any difference in effects of allogenic & autogenic FMT. 4.Time duration the altered gut microbiota stays healthy within recipients gut. 5.Statistical analysis will be performed using SPSS 16.0Timepoint: 1. Blood & stool monitoring after 7 days. 2. Gut microbiome monitoring after 1 month, 3 months, 6 months & 12 months. 3. Mean score improvement of IBS-SSS, IBS-QOL & GSRS scale at 3 months, 6 months & 12 months. 4. Mean score improvement of BAI, PHQ9 & MDQ scales

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Countries

India

Contacts

Public ContactDr Sayantan Banerjee

All India Institute of Medical Sciences(AIIMS), Kalyani

jayeeta.gastro@aiimskalyani.edu.in919432100747

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026