NCT02960074

Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients

Completed Phase 1 Last updated 5 September 2021

What this trial tests

Phase 1 trial testing Fecal Microbiota Capsule in Peanut Allergy in 15 participants. Completed in 28 July 2021.

Timeline

3 March 2017

Primary endpoint
28 July 2021

28 July 2021

Quick facts

Lead sponsor	Rima Rachid
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	3 March 2017
Primary completion	28 July 2021
Estimated completion	28 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Fecal Microbiota Capsule

Conditions studied

• Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

Rima Rachid — full company profile →

Who can join

Adults 18 to 40, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I trial to evaluate the safety and efficacy of oral encapsulated fecal microbiota transplantation (FMT) in the treatment of peanut allergy. In this research the investigators would like to learn more about ways to treat peanut allergies. There is currently no known cure for peanut allergy. The primary aim is to assess safety and tolerability of oral FMT in patients with peanut allergy aged 18-40 years.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Food allergy and the microbiome: Current understandings and future directions.
   Bunyavanich S, Berin MC. · · 2019 · cited 145× · PMID 31812181 · DOI 10.1016/j.jaci.2019.10.019
2. Fecal microbiota transplantation beyond Clostridioides difficile infections.
   Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
3. The gut microbiome in food allergy.
   Zhao W, Ho HE, Bunyavanich S. · · 2019 · cited 110× · PMID 30578857 · DOI 10.1016/j.anai.2018.12.012
4. Feast for thought: A comprehensive review of food allergy 2021-2023.
   Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918
5. The microbial origins of food allergy.
   Rachid R, Stephen-Victor E, Chatila TA. · · 2021 · cited 56× · PMID 33347905 · DOI 10.1016/j.jaci.2020.12.624
6. The Role of the Microbiome in Food Allergy: A Review.
   Nance CL, Deniskin R, Diaz VC, Paul M, et al · · 2020 · cited 42× · PMID 32466620 · DOI 10.3390/children7060050
7. Role of the Microbiome in Allergic Disease Development.
   Aguilera AC, Dagher IA, Kloepfer KM. · · 2020 · cited 27× · PMID 32548788 · DOI 10.1007/s11882-020-00944-2
8. Targeting type 2 immunity and the future of food allergy treatment.
   Berin MC. · · 2023 · cited 21× · PMID 36880703 · DOI 10.1084/jem.20221104