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Completed

NCT Number: NCT03100851

Effect of Probiotic on Constipation

Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS) shows potential effect on alleviating constipation. This study evaluated the impact of fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty acid and gut microbiota were also assessed.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • meet ROME Ⅲ criteria for functional constipation
  • normal body mass index between 18.5 and 29.9

Exclusion criteria

  • had a serious disease;
  • used systemic antibiotics or antimycotics medication and antidiarrheal or laxative medication in the 30 days prior to the study;
  • allergic to milk protein;
  • constipated because of organic or neurological lesions;
  • participated in any other studies within 2 months prior to this study.

Treatment and study plan

Lactobacillus casei strain Shirota

Dietary Supplement

a bottle of 100 mililiter probiotic dairy beverage containing 10^8 CFU Lactobacillus casei strain Shirota every day after lunch.

Primary outcomes

  1. change of stool consistency

    Time frame: change from baseline stool consistency at four-week intervention

  2. change of defecation frequency

    Time frame: change from baseline defecation frequency at four-week intervention

  3. change of constipation-related symptom scores

    Time frame: change from baseline constipation-related symptom scores at four-week intervention

Secondary outcomes

  1. Changes in stool short chain fatty acid content

    Time frame: change from baseline stool short chain fatty acid content at four-week intervention

  2. Changes in gut microbiota

    Time frame: change from baseline gut microbiota at four-week intervention

Sponsors and collaborators

Lead sponsor

China Agricultural University

Other

Registry information

Official study title

Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Chinese People With Constipation

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Jun 29, 2017

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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