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NCT05373784
FMT in Uncomplicated Diverticulitis
EARLY_PHASE1 trial testing Fecal Microbiota Transplantation (FMT) in Diverticulitis in 10 participants. Participants enrolled and being followed up; not accepting new ones.
30 March 2026
Quick facts
| Lead sponsor | Justin Maykel |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 15 March 2024 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fecal Microbiota Transplantation (FMT) — full drug profile →
Conditions studied
- Diverticulitis — all drugs for Diverticulitis →
- Uncomplicated Diverticular Disease — all drugs for Uncomplicated Diverticular Disease →
Sponsor
Justin Maykel
Who can join
18 and older, any sex, with Diverticulitis or Uncomplicated Diverticular Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fecal Microbiota Transplantation (FMT) is an established treatment for Clostridium difficile (C. diff) infection refractory to medical management. As C. diff infection usually arises due to significant disturbances in the gut microbiome, FMT is typically performed to restore a healthy microbiome among affected patients who have failed other treatments. Diverticulitis is a major, and often recurrent, source of morbidity in the U.S for which antibiotics and surgical resection constitute the only treatment options to date. Although alterations of the intestinal microbiome have also been shown among patients with diverticular disease, research on FMT in diverticulitis is sparse. The intended goal of this project is to determine the feasibility, effectiveness and safety of FMT in the treatment of uncomplicated diverticulitis, using clinical outcomes and microbiome analyses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05373784
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal Microbiota Transplantation (FMT)
Trials testing the same drug.
- NCT05911997 — MTC Versus FMT in for RCDI · Phase 1 · recruiting
- NCT05273255 — Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy · NA · completed
- NCT04997733 — Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal · Phase 3 · recruiting
- NCT04124211 — Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes · NA · unknown
- NCT03802461 — Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization · Phase 2, PHASE3 · suspended
Other recruiting trials for Diverticulitis
Currently open trials in the same condition.
- NCT07144683 — Anastomotic Leakage After Colorectal Surgery. · recruiting
- NCT07506005 — Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line · recruiting
- NCT05829343 — RObotic Versus LAparoscopic Colectomy for DIverticulitis. · recruiting
- NCT05681559 — Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial · NA · active not recruiting
- NCT04095663 — Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05373784 (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 Justin Maykel
- Last refreshed: 3 June 2025
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/NCT05373784.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing