Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension

NCT06518850 | Not Yet Recruiting Phase 1

• 1 other identifier: I-23PJ1228
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Most studies of bloating have focused on functional factors, while data on organic abdominal distention are rare, and studies that combine small intestine bacterial overgrowth and/or oral cecum transit time abnormalities are more urgent to explore. On this basis, patients with functional abdominal distension complicated with small intestine bacterial overgrowth were divided according to whether there was abnormal oral cecum transit time, and given the same treatment plan. The relief effect of abdominal distension, small intestine bacterial overgrowth turning negative and oral cecum transit time recovery were observed, so as to further clarify the cause of abdominal distension patients.

Conditions

Small Intestine Bacterial Overgrowth

Keywords

small intestine bacterial overgrowth; oral cecum transit time; abdominal distention

Outcome Measures

Primary Outcomes (4)

• Part 1 Positive rate of small intestinal bacterial overgrowth

  Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension

  1 day

• Part 1 Abnormal rate of oral cecum transit time

  Abnormal rate of oral cecum transit time in organic and functional abdominal distension

  1 day

• Part 2 Effective rate of abdominal distension

  Total effective rate (%) = Obvious effective rate (%) + Effective rate (%) 1. Obvious effect: the degree and frequency of abdominal distension score improved, or even completely disappeared, small intestinal bacterial overgrowth negative 2. Effective: the degree and frequency of abdominal distension score improved, small intestinal bacterial overgrowth positive 3. Ineffective: the degree and frequency of abdominal distension score did not improve

  2 weeks

• Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time

  1. Negative conversion rate of small intestinal bacterial overgrowth (%) =Number of small intestinal bacterial overgrowth negative after treatment/ Number of functional abdominal distention in Part 2\*100% 2. Negative conversion rate of oral cecum transit time (%) =Number of oral cecum transit time normal after treatment/ Number of experimental in Part 2\*100%

  2 weeks

Study Arms (2)

Sham Comparator（Normal oral cecum transit time）

SHAM COMPARATOR

Normal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment.

Drug: Rifaximin

Experimental（Abnormal oral cecum transit time）

EXPERIMENTAL

Abnormal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment.

Drug: Rifaximin

Interventions

Rifaximin DRUG

Both groups were treated with rifaximin for 14 days, during which follow-up records were reported by the subjects in the daily reference case report form. Methane and hydrogen breath tests were repeated 2 weeks after withdrawal.

Experimental（Abnormal oral cecum transit time）; Sham Comparator（Normal oral cecum transit time）

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
• Age 18-60 years old and gender;
• The chief complaint is abdominal distension and/or abdominal distension, abdominal distension and/or abdominal distension more prominent than other symptoms.
• Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
• Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
• No drug contraindications.

You may not qualify if:

• Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
• Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded;
• History of malignant tumors, history of abdominal surgeries;
• Food intolerance, confirmed or suspected lactose intolerance;
• Diagnosis of urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.) and other diseases outside the digestive system;
• Antibiotics and microecological preparations should be used within two weeks. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.
• Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
• Antibiotics and microecological preparations should be used within two weeks;
• Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Navy General Hospital, Beijing: collaborator
• Air Force Military Medical University, China: collaborator
• Beijing Tongren Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• The Luhe Teaching Hospital of the Capital Medical University: collaborator
• China-Japan Friendship Hospital: collaborator
• Beijing Aerospace General Hospital: collaborator
• Beijing Jishuitan Hospital: collaborator
• Peking University Third Hospital: collaborator

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Jing-Nan Li, MD,Ph.D

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Nan Li, MD,Ph.D

CONTACT

13601235229; Jing-NanLilijn2008@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 24, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07