Clinical Study of Resistant Starch in Improving Constipation

NCT06292949 | Recruiting

• 1 other identifier: TJ-IRB20230956
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation

Keywords

Resistant starch; Gut microbiota

Outcome Measures

Primary Outcomes (5)

• Changes in constipation symptoms

  The results of the questionnaire filled out by the patients were collected and statistically analyzed, and the scores of constipation symptoms and PAC-QOL (patient assessment of constipation quality of life questionnaire) were tested by paired t-test. The higher the score, the more serious the constipation symptoms, and the lower the score means the relief of constipation symptoms. The minimum score of the scale is 0, the maximum score is 30, and a score of more than 15 can be regarded as constipation. The PAC-QOL is a specific scale for assessing the quality of life of patients with chronic constipation. The PAC-QOL consists of 28 items divided into four dimensions: worries and concerns (11 items), physical discomfort (4 items), psychological discomfort (8 items), and satisfaction (5 items). Each item was scored on a 5-point scale, and the more severe the illness, the higher the score.

  14 days

• Changes in the diversity of intestinal flora

  To analyse changes in the diversity of intestinal flora before and after the administration of resistant starch in patients. Alpha diversity is a combination of species richness and evenness in a designated ecosystem. the Bray-Curtis distance reflects the variability in community composition and structure, with greater distances resulting in greater variability between communities.

  14 days

• Changes in the relative abundance of species of intestinal flora

  To analyse the changes of relative abundance of species before and after the administration of resistant starch in patients.According to the species abundance table of each species, Krona analysis , relative abundance profile display, relative abundance cluster thermogram display, PCA and PCoA dimension reduction analysis, and Wilcoxon test of different species between groups were carried out.

  14 days

• Changes in the number of intestinal flora

  Analyse the changes in the number of fecal flora before and after the administration of resistant starch in patients with constipation. In order to demonstrate more visually the changes in flora abundance after administration of resistant starch, statistical analyses were carried out using the number of patients who had a 1.5-fold increase or decrease in intestinal flora abundance before and after administration of resistant starch in all patients

  14 days

• Changes in the metabolic function of intestinal flora

  According to the results of gene annotation, the ko gene family was mapped to KEGG database, and the annotation information of metabolic function was obtained, and the difference of metabolic function of fecal flora before and after taking resistant starch in constipation patients was analyzed.

  14 days

Study Arms (1)

Resistant starch intervention group

EXPERIMENTAL

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.

Dietary Supplement: Resistant starch

Interventions

Resistant starch DIETARY_SUPPLEMENT

Constipated patients take 1 pack of resistant starch (20g/pack) daily for 14 days

Resistant starch intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Colonoscopy excludes patients with colorectal tumors within one or two years

Sponsors & Collaborators

• Huaping Xie: lead

Study Sites (1)

Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Constipation

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• ping h Xie

  Tongji Medical College of Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

ping h Xie

CONTACT

86+13437187007; hpxie@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 5, 2024
• Study Start: September 27, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)