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

NCT ID: NCT06277505

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-06-01

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.

Detailed Description

The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation.

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prebiotics and probiotics，life-style

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

Group Type: EXPERIMENTAL

Take prebiotics and probiotics

Intervention Type: 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

lifestyle guidance

Intervention Type: BEHAVIORAL

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

life-style

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

Group Type: OTHER

lifestyle guidance

Intervention Type: BEHAVIORAL

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

Interventions

Take prebiotics and probiotics

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

Intervention Type: COMBINATION_PRODUCT

lifestyle guidance

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

Intervention Type: BEHAVIORAL

Other Intervention Names

behavioral

Eligibility Criteria

Inclusion Criteria

1. Age: between 18 and 60 years old

2. Functional constipation was diagnosed using Rome IV criteria.

3. No other relevant medications that may affect the gut microbiota before the start of the experiment

4. Ability to participate

5. Consent to participate in the study

Exclusion Criteria

1. Organic constipation (such as intestinal obstruction, bowel cancer, etc.)

2. Outlet obstructive constipation

3. Previous abdominal, rectal, or perianal surgery except cholecystectomy, appendectomy, tubal ligation, and cesarean section

4. Patients with constipation-oriented irritable bowel syndrome (IBS-C) or functional abdominal pain syndrome who meet Rome IV criteria

5. a serious mental illness or any medical condition related to it

6. Diseases of the small or large intestine, such as ulcerative colitis and Crohn's disease

7. There are serious important organs such as respiratory, heart, liver, kidney and other functional insufficiency

8. Use probiotics, prebiotics and/or Biostime within 1 month

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Xiamen Univisity

Xiamen, Fujian, China

Countries

China

Other Identifiers

2023(164)

Identifier Type: -

Identifier Source: org_study_id