NCT06292949

Clinical Study of Resistant Starch in Improving Constipation

Effect of Resistant Starch on Symptom Improvement and Intestinal Microbiome in Patients With Functional Constipation
Huaping Xie·ClinicalTrials.gov·dietary supplementRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Constipation
Drug/Device/Intervention
Resistant starch
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Huaping Xie
Funder
Tongji Hospital
Location
Wuhan, China
Timeline & enrollment
Phase
N/A
Start date
Sep 27, 2023
End date
Sep 25, 2024
Enrollment
30 participants
Primary outcome

Changes in constipation symptoms,Changes in the diversity of intestinal flora,Changes in the relative abundance of species of intestinal flora,Changes in the number of intestinal flora,Changes in the metabolic function of intestinal flora

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.

ICD-10 classifications
ConstipationIrritable bowel syndrome with predominant constipation [IBS-C]Other laxativesPoisoning: Other laxativesOther functional intestinal disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06292949
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06292949 through Pure Global AI's free database. This phase not specified trial is sponsored by Huaping Xie and is currently Recruiting. The study focuses on Constipation. Target enrollment is 30 participants.

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