Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

2 Jan 2026 → ongoing

Decision date (initial)

2025-06-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

Evaluate the impact of the gut microbiota, and of its alteration in inflammatory bowel disease, on peripheral immune cells energy metabolism.

Secondary objectives 2

1. Evaluate the impact of the gut microbiota and its alteration in inflammatory bowel disease on the fate of microbiota-derived carbon sources in host cells
2. Identify the intestinal bacteria involved in this process we will use SIP-DNA and SIP-RNA sequencing approaches (Fortunato and Huber, 2016; Neufeld et al., 2007; Ziels et al., 2018).

Conditions and MedDRA coding

Healthy volunteers : Healthy adults with no history of gastrointestinal disease Patients with IBD in remission

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. For volunteers: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 km/m²
2. For volunteers: For women, female of child-bearing age with an active contraception (hormonal, intrauterine device, bilateral tubal occlusion, sexual abstinence*) and this during at least the period of treatment (up to v2)
3. For volunteers: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
4. For volunteerss: - Patient with health insurance (AME except)
5. For volunteers: Informed Written consent
6. Patients with IBD: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 kg/m²
7. Patients with IBD: Crohn’s Disease (Excepting disease involving only the upper GI tract) or ulcerative colitis (excepting disease involving only the rectum), according to the Lennard-Jones criteria for at least 6 months (15 patients with Crohn’s disease and 15 with ulcerative colitis will be recruited)
8. Patients with IBD: Patient in steroid-free clinical remission for at least 6 months (for Crohn’s disease: CDAI <150 the week before inclusion, for ulcerative colitis: Partial Mayo Clinic score of 0 or 1).
9. Patients with IBD: Female of child-bearing age with an active contraception. Efficient contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate <1%)
10. Patients with IBD: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
11. Patients with IBD: Patient with health insurance (AME except)
12. Patients with IBD: Informed Written consent

Exclusion criteria 24

1. Healthy volunteers: Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration or history of abdominal surgery (except appendectomy).
2. Healthy voluteers: contra-indications to the administration of gentamicin (refer to SmPC)
3. Healthy volunteers: Participation in any other interventional study
4. Healthy volunteers: under legal protection
5. Patients with IBD: Pregnant or breastfeeding women
6. Patients with IBD: blood donation in the 3 months before the study
7. Patients with IBD: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0
8. Patients with IBD: probiotics in the month preceding day 0 and during the study
9. Patients with IBD: Ileal resection > 50cm or colectomy
10. Patients with IBD: Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
11. Patients with IBD: Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion
12. Healthy volunteers: Curative long-term treatment
13. Patients with IBD: Participation in any other interventional study
14. Patients with IBD: Patients under legal protection
15. Patient with IBD: Diagnosis of ulcerative colitis restricted to the rectum
16. Healthy volunteers : Pregnant or breastfeeding women
17. Healthy volunteers : blood donation in the 3 months before the study
18. Healthy volunteers: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1)
19. Healthy volunteers : probiotics in the month preceding day 0 (V1)
20. Healthy volunteers: consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0
21. Healthy volunteers: abdominal surgery in the past (except for appendectomy)
22. Healthy volunteers: allergy against the antibiotics and antifungal treatment used in this study or to their excipients
23. Healthy volunteers: fructose intolerance
24. Patient with IBD: Fructose intolerance

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Energy metabolism of major immune cell types for peripheral blood will be assessed on a blood sample. The energy metabolism will be assessed by single-cell energetic metabolism by profiling translation inhibition

Secondary endpoints 2

1. Impact of the gut microbiota and its alterations in inflammatory bowel disease on the fate of microbiota-derived carbon sources in host cells: we will use a strategy based on stable isotope probing (SIP). The participants will receive orally food grade inulin from Chicory (2% labelled with 13C) at H0 on day 0 (v1) and day 7 (v2) for healthy adults and day 0 (v1) only for patients with IBD. The incorporation of 13C in metabolites will then be assessed
2. Identification of the intestinal bacteria responsible for the metabolism of the labeled inulin: we will use SIP-DNA and SIP-RNA sequencing approaches: DNA and RNA will be extracted from each fecal samples obtained

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications