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Recruiting

NCT Number: NCT06781827

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

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology Department of Jiangsu Province （Suqian）Hospital

Suqian, Jiangsu, 223800, China

Location status: Recruiting

Location contact

Huanhuan Chen, Doctor

CONTACT

[email protected]

18351093039

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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
  • Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
  • There is currently an infection
  • He has had cancer in the last 5 years -

Treatment and study plan

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).

Primary outcomes

  1. Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System

    Time frame: 12 months

    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.

Secondary outcomes

  1. Assessment of Intestinal Flora Changes Using 16S RNA Analysis

    Time frame: 8 weeks

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

  2. Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers

    Time frame: 8 weeks

    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.

  3. Disease progression

    Time frame: 8 weeks

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

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

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huanhuan Chen, Doctor

CONTACT

[email protected]

18351093039

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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