Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Gut Microbiota; IBS - Irritable Bowel Syndrome

Treatments: Drug: Rifaximin; Drug: Probiotic Formula; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04074421

(2019) Study No. 413

Details and patient eligibility

About

We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.

Full description

According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 years old;
• in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV；
• blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem;
• no intestinal warning symptoms

Exclusion criteria

• suffering from severe heart, lung, liver, kidney, nervous system diseases;
• suffering from mental disorders caused by schizophrenia, brain organic and physical diseases;
• suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease);
• History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy);
• pregnant or lactating women;
• have undergone colonoscopy in the past month or accept other bowel preparation operations;
• In the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, Chinese medicine and other drugs;
• have participated in other dietary treatments;
• understand communication barriers, unable to communicate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

240 participants in 3 patient groups, including a placebo group

Rifaximin group

Active Comparator group

Description:

Repeating treatment of Rifaximin

Treatment:

Drug: Rifaximin

Probiotics group

Sham Comparator group

Description:

Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium

Treatment:

Drug: Probiotic Formula

Placebo group

Placebo Comparator group

Description:

Placebo control group

Treatment:

Drug: Placebo oral tablet