Study on EXL01 for Preventing Crohn’s Disease Recurrence After Surgery in Patients

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What is this study about?

This clinical trial is focused on studying Crohn’s disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The trial will test a new treatment called EXL01, which is a type of live biotherapeutic product, meaning it contains living microorganisms that are intended to help maintain or restore a healthy balance of bacteria in the gut. The study will also use a matching placebo for comparison.

The purpose of this study is to evaluate the safety and effectiveness of EXL01 in preventing the recurrence of Crohn’s disease after surgery. Participants in the study will be randomly assigned to receive either the EXL01 treatment or a placebo. The study will last for about six months, during which participants will take the treatment orally in capsule form. Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the progress of their condition.

The main goal is to compare the outcomes of those treated with EXL01 to those who receive the placebo, specifically looking at the recurrence of Crohn’s disease symptoms after surgery. This will be assessed using a method called endoscopy, which involves using a camera to look inside the digestive tract. The study aims to provide valuable information on whether EXL01 can help prevent the return of Crohn’s disease symptoms after surgery, potentially offering a new option for managing this challenging condition.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the EXL01 capsule or a matching placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

2 medication administration

Participants take the assigned capsule orally. The specific dosage and frequency are determined by the study protocol and are followed throughout the trial duration.

3 monitoring and assessments

Regular assessments are conducted to monitor the participant’s health and response to the treatment. These include endoscopic evaluations at various intervals, with a primary focus at 6 months post-surgery.

The modified Rutgeerts score is used to assess the condition of the intestines. This score is determined through endoscopic procedures, which involve using a camera to view the inside of the intestines.

4 data collection

Throughout the trial, data is collected on various health indicators, including the Crohn’s Disease Activity Index (CDAI), patient-reported outcomes, and levels of specific proteins and bacteria in the body.

These assessments help determine the effectiveness of the treatment in preventing the recurrence of Crohn’s disease after surgery.

5 end of treatment

The study concludes with a final assessment at 24 weeks or at the end of treatment. This includes a comprehensive evaluation of the participant’s condition using endoscopy and other diagnostic tools.

The results are analyzed to determine the success of the treatment in preventing the recurrence of Crohn’s disease.

Who Can Join the Study?

The patient must be a male or female who is 18 years or older at the time they agree to participate in the study.
The patient must have been diagnosed with Crohn’s disease (CD), which affects the ileum (a part of the small intestine) for at least 3 months before the screening process.
The patient must have had a surgery called ileocecal resection or ileo-colonic resection (removal of a part of the intestine) between 5 days to 5 weeks before being randomly assigned to a treatment group.
The patient should not be scheduled to receive any treatment for Crohn’s disease or anti-TNF agents (medications that reduce inflammation) in the 6 months following the surgery.

Who Cannot Join the Study?

Patients who have not had surgery related to Crohn’s disease. Crohn’s disease is a condition that causes inflammation in the digestive tract.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend follow-up visits.
Patients who have other medical conditions that might interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of allergic reactions to the study medication or similar medications.
Patients who have used certain medications that might affect the study results.
Patients who have a history of substance abuse or alcohol dependency.
Patients who have a mental health condition that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU d’Estaing	Clermont Ferrand	France
Hôpital Archet 2	Nice	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Saint Eloi	Montpellier	France
Hopital Huriez	Lille	France
Cgg Mjwrcyaxn &vawvrg Hgfvuax Niqp	Marseille	France
Arxivakylj Poemvboo Hhnyocpk Di Ptaad	Paris	France
Ceiq Dr Nygep	Vandoeuvre Les Nancy	France
Hxihwlf Hzooz Muvtwz &emtvjr 1 rzs Gaeayrs Enxgtg	Creteil	France
Chy Keawjol Bokrpoc	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.01.2025

Trial locations

Investigated drugs:

Exl01

EXL01 is a medication being studied to see if it can help prevent Crohn’s Disease from coming back after surgery. Crohn’s Disease is a condition that causes inflammation in the digestive tract, and sometimes surgery is needed to remove the affected parts. This medication is being tested to see if it can keep the disease from returning after such surgeries.

Crohn’s disease – Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. Over time, the disease can cause damage to the digestive tract, potentially affecting its ability to absorb nutrients. The progression of Crohn’s disease is unpredictable, with symptoms and severity differing from person to person.

Trial ID:

2024-511357-22-00

Protocol code:

REMIND-2024-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on EXL01 for Preventing Crohn’s Disease Recurrence After Surgery in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?