Trials Sponsors Conditions Drugs Pricing

Conditions

Small Intestine Bacterial Overgrowth

Keywords

small intestine bacterial overgrowthoral cecum transit timeabdominal 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

RifaximinDrug

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）

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Peking University Third Hospital
Othercollaborator
Beijing Friendship Hospital
Othercollaborator
China-Japan Friendship Hospital

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic 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 2
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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2024

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

Sham Comparator（Normal oral cecum transit time）

Experimental（Abnormal oral cecum transit time）

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

Sham Comparator（Normal oral cecum transit time）

Experimental（Abnormal oral cecum transit time）

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record