Effect of Resistant Starch on Symptom Improvement and Intestinal Microbiome in Patients With Functional Constipation

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The clinical manifestation is constipation, which meets the diagnostic criteria of Roman IV constipation.

Locations
Other Locations
China
Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology
RECRUITING
Wuhan
Contact Information
Primary
ping h Xie
hpxie@tjh.tjmu.edu.cn
86+13437187007
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2024-09-25
Participants
Target number of participants: 30
Treatments
Experimental: Resistant starch intervention group
or the recruited patients with functional constipation, stool samples were collected and 2 packets of resistant starch were taken every day, each packet of 10g. The resistant starch was brewed with 200ml warm water for 14 days, and the fecal samples of volunteers were collected on the 0th, 7th and 14th day. Patients filled out questionnaires on days 0 and 14 to evaluate the improvement of constipation symptoms.
Sponsors
Leads: Huaping Xie

This content was sourced from clinicaltrials.gov