Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

Constipation Clinical Trial

Official title:

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667884
• Other study ID #: 201911143
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: Health Science Center of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional constipation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 30, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults: 18 to 70 years old (not less than 50% of the final population over 45 years old, and not less than 30% of men);

2. Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); * Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months

Exclusion Criteria:

1. Pregnant and lactating women;

2. Unable to take the test sample and complete the inspection items as required due to inability to take food by mouth, weakness, allergies or other reasons (including the inability to complete all items due to recent travel plans);

3. Unclear main complaint and obvious abnormal mental state;

4. The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);

5. Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;

6. Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week

7. Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;

8. Have been diagnosed with the following diseases: severe systemic diseases such as stroke, heart disease, liver cirrhosis, renal failure, hematopoietic system, or qualitative intestinal diseases caused by colonoscopy or imaging display;

9. In the past 3 months, there are often abdominal pain, abdominal pain accompanied by changes in bowel characteristics or frequency, blood in the stool, diarrhea or involuntary weight loss;

10. Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Prebiotics or Probiotics
All the supplements were provided in solid drinks,and required to drink with plain water 35-40?, and lifestyle intervention was provided to all the groups by reading materials.

Locations

Country	Name	City	State
China	Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Health Science Center of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bowel movements per week	bowel movements will be recorded per week	week 0 to 4
Secondary	Classification of bowel status	Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation	day 0, 14, 28
Secondary	Bristol classification of stool characteristics	Bristol classification	day 0, 14, 28
Secondary	glucose	Fasting plasma	day 0, 14, 28
Secondary	HDL-C	Fasting plasma	day 0, 14, 28
Secondary	LDL-C	Fasting plasma	day 0, 14, 28
Secondary	TG	Fasting plasma	day 0, 14, 28
Secondary	Tch	Fasting plasma	day 0, 14, 28
Secondary	diversity and abundance of intestinal flora	16s rRNA	day 0, 14, 28