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National Registry for use of Faecal Microbiota Transplantation (FMT) in Inflammatory Bowel Disease (including Ulcerative Colitis and Crohns Disease)

The Indian Consortium on Faecal Microbiome Transfer in Inflammatory Bowel Disease (ICON-FMT) - ICON-FMT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028761
Enrollment
5000
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K50- Crohns disease [regional enteritis] Health Condition 2: K51- Ulcerative colitis

Interventions

None listed

Sponsors

Department of Gastroenterology Dayanand Medical College and Hospital Ludhiana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with IBD aged >= 18 years Written informed consent to participate Subject who has received FMT in past or planning to receive FMT

Exclusion criteria

Exclusion criteria: Age Pregnancy Known HIV positive. Disseminated or advanced malignancy. Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up. Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of study. Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease, indication and protocol for FMT.Timepoint: 1 year, 2 years, 5 years, 10 years

Secondary

MeasureTime frame
Comparison of disease severity, short and long term adverse events and their outcomes (include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases)Timepoint: 1 year, 2 years, 5 years, 10 years;Disease recurrence after FMTTimepoint: 1 year, 2 years, 5 years, 10 years;Patient outcomes of FMT: Safety and EfficacyTimepoint: 1 year, 2 years, 5 years, 10 years;To study and compare the criteria used for selecting donors for FMT. Timepoint: 1 year, 2 years, 5 years, 10 years;To study the different FMT protocols used (including method of preparation of faecal slurry, route, dose and frequency of administration of FMT)Timepoint: 1 year, 2 years, 5 years, 10 years

Countries

India

Contacts

Public ContactAjit Sood

Department of Gastroenterology, Dayanand Medical College and Hospital

ajitsood10@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026