Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWecare Probiotics Co., Ltd.

About this trial

This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be over 18 years old

Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -

Disqualifiers

Does not meet the diagnostic criteria of CD

Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc

Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness

Patients with suspected cancer in their intestines

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times (January, March, June, and December).

  • Maltodextrin

    Dietary supplement

    The experimental phase of this study had last 8 weeks and each patient will make 4 visits (January, March, June, and December).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ProbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System

The intestinal inflammation will be assessed using the Endoscopic Scoring System, which will be observed under endoscope at 1 month, 3 months, 6 months, and 12 months after the administration of the drug.

Time frame
12 months

Secondary outcomes

1

Assessment of Intestinal Flora Changes Using 16S RNA Analysis

Part of the intestinal fluid was collected under endoscope, and 16S RNA analysis was conducted to evaluate the changes in the intestinal flora composition.

Time frame
8 weeks
2

Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers

The inflammatory changes were detected by analyzing peripheral blood for specific inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and other relevant cytokines.

Time frame
8 weeks
3

Disease progression

The progress of the disease was assessed by collecting fecal samples to detect the change of calcarein

Time frame
8 weeks
4

Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI)

The Crohn's Disease Activity Index (CDAI) was used to evaluate the disease severity of CD. The CDAI score ranges from 0 to 600, with higher scores indicating more severe disease. The index is calculated by combining the daily frequency of bowel movements, abdominal pain score (0-10), general well-being (0-7), and the presence of abdominal mass (0-2). Additionally, the Simple Endoscopic Score for Crohn's Disease (SES-CD) was used for endoscopic scores, which ranges from 0 to 42, with higher scores indicating more severe endoscopic findings.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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