Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation.

NCT06277505 | Enrolling By Invitation

• 1 other identifier: 2023(164)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we will evaluate the efficacy of prebiotics combined with quadruple probiotics in the treatment of functional constipation through an open RCT study. The experimental group received lifestyle guidance and combined intervention of prebiotics and quadruple probiotics at the same time. The patients took the combination of prebiotics and probiotics twice a day during the treatment period. The control group received only lifestyle instruction. At the same time, to evaluate the safety of probiotics combined with quadruple probiotics in the treatment of functional constipation, and provide a new treatment plan for clinical treatment of functional constipation.

Conditions

Functional Constipation

Keywords

prebiotics; probiotics; functional constipation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in the number of fully autonomous bowel movements per week at the end of treatment

  Change in the number of fully autonomous bowel movements per week at the end of treatment

  A month after treatment

Study Arms (2)

Prebiotics and probiotics，life-style

EXPERIMENTAL

Take 3.5g prebiotic +2g probiotic twice a day before meals; At the same time, lifestyle guidance is given, including adjusting dietary structure, increasing the intake of foods high in dietary fiber and moderate exercise

Combination Product: Take prebiotics and probiotics; Behavioral: lifestyle guidance

life-style

OTHER

lifestyle guidance is given, including adjusting dietary structure, increasing the intake of foods high in dietary fiber and moderate exercise

Behavioral: lifestyle guidance

Interventions

Take prebiotics and probiotics COMBINATION_PRODUCT

Take 3.5g prebiotic +2g prebiotic twice a day before meals; At the same time, lifestyle guidance is given, including adjusting dietary structure, increasing the intake of foods high in dietary fiber and moderate exercise

Also known as: behavioral

Prebiotics and probiotics，life-style

lifestyle guidance BEHAVIORAL

lifestyle guidance is given, including adjusting dietary structure, increasing the intake of foods high in dietary fiber and moderate exercise

Prebiotics and probiotics，life-style; life-style

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: between 18 and 60 years old
• Functional constipation was diagnosed using Rome IV criteria.
• No other relevant medications that may affect the gut microbiota before the start of the experiment
• Ability to participate
• Consent to participate in the study

You may not qualify if:

• Organic constipation (such as intestinal obstruction, bowel cancer, etc.)
• Outlet obstructive constipation
• Previous abdominal, rectal, or perianal surgery except cholecystectomy, appendectomy, tubal ligation, and cesarean section
• Patients with constipation-oriented irritable bowel syndrome (IBS-C) or functional abdominal pain syndrome who meet Rome IV criteria
• a serious mental illness or any medical condition related to it
• Diseases of the small or large intestine, such as ulcerative colitis and Crohn's disease
• There are serious important organs such as respiratory, heart, liver, kidney and other functional insufficiency
• Use probiotics, prebiotics and/or Biostime within 1 month

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen Univisity

Xiamen, Fujian, 350000, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-03

Locations

CN (1)