Who is sponsoring NCT02428361?

NCT02428361 is sponsored by Najwa Elnachef.

What drugs are being tested in NCT02428361?

Interventions in NCT02428361: Biologically active human fecal material, OpenBiome.

Is NCT02428361 still recruiting?

NCT02428361 is currently completed. Last updated 18 April 2019.

Last reviewed 2019-04-18 · How we verify

NCT02428361

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fecal Microbiota Transplant (FMT) for Pouchitis

Completed EARLY_PHASE1 Last updated 18 April 2019

What this trial tests

EARLY_PHASE1 trial testing Biologically active human fecal material, OpenBiome in Pouchitis in 19 participants. Completed in 4 March 2019.

Timeline

28 May 2015

Primary endpoint
9 April 2018

4 March 2019

Quick facts

Lead sponsor	Najwa Elnachef
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	28 May 2015
Primary completion	9 April 2018
Estimated completion	4 March 2019
Sites	1 location across United States

Drugs / interventions tested

Biologically active human fecal material, OpenBiome — full drug profile →

Conditions studied

Pouchitis — all drugs for Pouchitis →

Sponsor

Najwa Elnachef — full company profile →

Who can join

18 and older, any sex, with Pouchitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, open label pilot study in which patients with symptoms of acute or chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims our: 1. To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial Transplantation. 2. To determine if endoscopic appearance of ileal pouch improves following treatment by Fecal Microbial Transplantation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Pouchitis

Currently open trials in the same condition.

NCT06443502 — A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pou · Phase 3 · recruiting
NCT03524352 — the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis · Phase 3 · active not recruiting
NCT04912999 — Inflammatory Bowel Diseases Remission Registry · recruiting
NCT03545386 — Fecal Microbiota Transplantation for Pouchitis · Phase 2 · recruiting

Other Najwa Elnachef trials

Trials by the same sponsor.

NCT03006809 — Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02428361 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Najwa Elnachef
Last refreshed: 18 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02428361.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing