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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;

No drug contraindications.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Sham Comparator(Normal oral cecum transit time)Sham comparator 1 intervention
Group B: Experimental(Abnormal oral cecum transit time)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 Positive rate of small intestinal bacterial overgrowth

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

Time frame
1 day
2

Part 1 Abnormal rate of oral cecum transit time

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

Time frame
1 day
3

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

Time frame
2 weeks
4

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%

Time frame
2 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

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

This trial is not recruiting at the moment. You can still explore other options: