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Search / Trial NCT06277505

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

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Feb 18, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Prebiotics Probiotics Functional Constipation Randomized Controlled Trial

ClinConnect Summary

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)...

Gender

ALL

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

About The First Affiliated Hospital Of Xiamen University

The First Affiliated Hospital of Xiamen University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and trials. As a prominent teaching hospital, it combines state-of-the-art facilities with a commitment to high-quality patient care and medical education. The hospital is at the forefront of various clinical studies, focusing on a wide array of specialties, and aims to enhance treatment methodologies and improve patient outcomes. With a team of experienced researchers and clinicians, the First Affiliated Hospital of Xiamen University plays a critical role in contributing to medical knowledge and addressing pressing health challenges.

Locations

Xiamen, Fujian, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported