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New treatment option for IBD
Official title Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT07300553
What this study is testing
What is Vancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg?
Vancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ibd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Inflammatory Bowel Disease (IBD) often leads to poor disease control and reduced quality of life. Changes in the gut microbiota may disrupt the energy metabolism of immune cells, contributing to IBD.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy volunteer
- Age ≥ 18 years and \< 50 years
- 17 kg/m² \< body mass index \< 25 kg/m² (microbiota modified based on BMI, (Le Chatelier et al., 2013)
- For women, female of child-bearing age with an active contraception (hormonal, intrauterine device, bilateral tubal occlusion, sexual abstinence\ )...
- A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile...
You likely can't join if
- Healthy volunteers :
- Clinically significant abnormal serum/ plasma levels of electrolytes, creatinine, liver enzymes, thyroid stimulating hormone or blood cell count at...
- Infectious episode requiring antimicrobial treatment since V0
- Severe diarrhea (increase of seven or more stools per day over baseline) Patients with IBD - Infectious episode requiring antimicrobial treatment...
See the full eligibility criteria
- Healthy volunteer
- Age ≥ 18 years and \< 50 years
- 17 kg/m² \< body mass index \< 25 kg/m² (microbiota modified based on BMI, (Le Chatelier et al., 2013)
- 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) \ Sexual...
- A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral...
- Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- Patient with health insurance (AME except)
- Informed Written consent Patient with IBD
- Age ≥ 18 years and \< 50 years
- 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...
- 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).
- 17 kg/m² \< body mass index \< 25 kg/m²
- 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...
- Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- Patient with health insurance (AME except)
- Informed Written consent Non Healthy volunteers
- Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration
- Curative long-term treatment
- Pregnant or breastfeeding women\ \ \ \ A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods...
- blood donation in the 3 months before the study
- Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1)
- probiotics in the month preceding day 0 (V1),
- consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0
- abdominal surgery in the past (except for appendectomy)
- allergy against the antibiotics and antifungal treatment used in this study or to their excipients
- contra-indications to the administration of gentamicin (refer to SmPC)
- Participation in any other treatment study
- Patients under legal protection Patients with IBD
- Pregnant or breastfeeding women
- blood donation in the 3 months before the study
- Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0
- probiotics in the month preceding day 0 and during the study,
- Ileal resection \> 50cm or colectomy
- Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- Diagnosis of ulcerative colitis restricted to the rectum.
- 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
- Participation in any other treatment study
- Patients under legal protection
- Healthy volunteers :
- Clinically significant abnormal serum/ plasma levels of electrolytes, creatinine, liver enzymes, thyroid stimulating hormone or blood cell count at the biological check-up of the visit v0 (screening and inclusion)
- Infectious episode requiring antimicrobial treatment since V0
- Severe diarrhea (increase of seven or more stools per day over baseline) Patients with IBD - Infectious episode requiring antimicrobial treatment since V0 \- IBD flare
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.