Clinical trial NCT04074421: Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
Official title: Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IBS - Irritable Bowel Syndrome
Gut Microbiota
Keywords: Rifaximin
Probiotics
IBS-D
gut microbiota
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: RenJi Hospital
name: Peking Union Medical College Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: The Central Hospital of Lishui City
First posted: 2019-08-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the IBS symptom grade score
timeFrame: baseline
measure: the quality of life score
timeFrame: baseline
measure: the IBS symptom grade score
timeFrame: 2 weeks
measure: the quality of life score
timeFrame: 2 weeks
measure: the IBS symptom grade score
timeFrame: 12 weeks
measure: the quality of life score
timeFrame: 12 weeks
measure: 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
timeFrame: 12 weeks
measure: 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
timeFrame: baseline
measure: 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Liangjing Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: