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Completed

NCT Number: NCT04375475

Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health

This was a randomized, double-blind, single-center, placebo-controlled, three-arm study.

The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic Flavored Yogurt on:

Improving gastrointestinal health; Relieving symptoms of functional constipation or functional diarrhea; Improving gut immunity; Adjusting microbiological flora in gastrointestinal tract.

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Key information

Conditions

Intestinal Health

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiaoton University Affiliated Xinhua Hospital

Shanghai, 200092, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged 25-45 years old;
  • Functional constipation or diarrhea diagnosed by Rome III criteria;
  • Agree not to take any dietary supplements or dairy products other than the study products during the study period;
  • Agree not to take any supplements or dairy products containing prebiotics/probiotics other than the study products during the study period;
  • Agree not to participant in other interventional studies during the study period;
  • Fully understand the property, purpose, benefits and potential risk and side effect from the study;
  • Agree to follow all study requirements and procedures;
  • Signed informed consent.

Exclusion criteria

  • Currently receiving treatment for gastrointestinal symptoms;
  • Lactose intolerance;
  • Having diseases or conditions that may affect intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, or Anorexia nervosa;
  • Currently under diet control or in use of medicine or supplements for weight control or that might affect appetite;
  • Have had laxatives or other substance that will enhance digestion within two weeks before the study begins;
  • Have had dairy products or other food containing probiotics within 10 days before the study begins;
  • Currently having diarrhea;
  • Currently pregnant or breast-feeding, or plan to be pregnant during the study period;
  • Not be able to follow study procedures according to investigators evaluation.

Treatment and study plan

Bright Changyou probiotic flavored yogurt

Dietary Supplement

Oral consumption of Bright Changyou probiotic flavored yogurt 100 g at a time and twice per day for 28 days. The experimental product has similar package and taste as the comparators.

Bright Changyou lactobacillus flavored yogurt

Dietary Supplement

Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.

Bright flavored yogurt

Dietary Supplement

Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.

Primary outcomes

  1. Gastrointestinal health score

    Time frame: Day 0, 28

    Change of the total gastrointestinal health score at day 28 from baseline. The total score is the sum of the 4 aspects of gastrointestinal health (each with score range from 0 to 3):

    Weekly stool frequency (>=6; 4-6; 1-3; 0); Ratio of the number of unopened defecation to the total number of defecation (1; 1/4; 1/3; >=1/2); Duration of defecation (<5 minutes; 5-15 minutes; 16-30 minutes; >=30 minutes); Defecation condition (normal perception; straining/uncomfortableness at stool; obvious straining/uncomfortableness or difficulty at defecation with little feces amount; frequent abdominal or anus pain that affect defecation).

Secondary outcomes

  1. Defecation satisfaction score

    Time frame: Day 0, 3, 7, 14, 21, 28

    Total score of the satisfaction on 4 aspects of defecation habit (each with score range from 0 to 3):

    Stool frequency, defecation duration, stool characteristics, and defecation habit (very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied)

  2. Bristol score of stool characteristics

    Time frame: Day 0, 3, 7, 14, 21, 28

    • Separate hard lumps, like nuts;
    • Sausage-shaped but lumpy;
    • Like a sausage but with cracks on the surface;
    • Like a sausage or snake, smooth and soft;
    • Soft blobs with clear-cut edges;
    • Fluffy pieces with ragged edges, a mushy stool;
    • Watery, no solid pieces, entirely liquid.

  3. Bristol score of stool color

    Time frame: Day 0, 3, 7, 14, 21, 28

    Score from 1 to 7 for stool color from light to dark

  4. Symptom score of digestive system

    Time frame: Day 0, 3, 7, 14, 21, 28

    Total score of the 9 aspects of digestive symptoms (each with score range from 0 to 3 indication no symptom, light symptom, moderate symptom and severe symptom):

    Bloating, abdominal pain, gastric distention, heavy stomach, loss of appetite, belching, intestinal colic, and abdominal colic.

  5. Fecal bacterium

    Time frame: Day 0, 14

    Quantitative measurements of clostridium perfringens bacteria, lactobacillus, bifidobacterium and Escherichia coli.

  6. Fecal short chain fatty acids

    Time frame: Day 0, 14

    Percentage of acetic acid, propionic acid and butyric acid

  7. Fecal secretory immunoglobulin A (sIgA)

    Time frame: Day 0, 14

    Fecal concentration of sIgA

Sponsors and collaborators

Lead sponsor

Bright Dairy & Food Co., Ltd

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 5, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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