Clinical trial NCT04667884: Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation
Official title: Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of bowel movements per week
timeFrame: week 0 to 4
Secondary outcomes:
measure: Classification of bowel status
timeFrame: day 0, 14, 28
measure: Bristol classification of stool characteristics
timeFrame: day 0, 14, 28
measure: glucose
timeFrame: day 0, 14, 28
measure: HDL-C
timeFrame: day 0, 14, 28
measure: LDL-C
timeFrame: day 0, 14, 28
measure: TG
timeFrame: day 0, 14, 28
measure: Tch
timeFrame: day 0, 14, 28
measure: diversity and abundance of intestinal flora
timeFrame: day 0, 14, 28
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: Xi'an Jiaotong University
name: Xin Liu
role: PRINCIPAL_INVESTIGATOR
References: