Clinical Study of Resistant Starch in Improving Constipation - Trial NCT06292949

Timeline & Enrollment

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