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Effect of Probiotic on Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lactobacillus casei strain Shirota
Sponsored by
China Agricultural University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    LcS intervention

    Arm Description

    Patients with constipation received dietary supplement with Lactobacaiilus casei strain Shirota.

    Outcomes

    Primary Outcome Measures

    change of stool consistency
    change of defecation frequency
    change of constipation-related symptom scores

    Secondary Outcome Measures

    Changes in stool short chain fatty acid content
    Changes in gut microbiota

    Full Information

    First Posted
    March 29, 2017
    Last Updated
    June 28, 2017
    Sponsor
    China Agricultural University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03100851
    Brief Title
    Effect of Probiotic on Constipation
    Official Title
    Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Chinese People With Constipation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2, 2015 (Actual)
    Primary Completion Date
    September 26, 2016 (Actual)
    Study Completion Date
    March 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Agricultural University

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LcS intervention
    Arm Type
    Experimental
    Arm Description
    Patients with constipation received dietary supplement with Lactobacaiilus casei strain Shirota.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus casei strain Shirota
    Intervention Description
    a bottle of 100 mililiter probiotic dairy beverage containing 10^8 CFU Lactobacillus casei strain Shirota every day after lunch.
    Primary Outcome Measure Information:
    Title
    change of stool consistency
    Time Frame
    change from baseline stool consistency at four-week intervention
    Title
    change of defecation frequency
    Time Frame
    change from baseline defecation frequency at four-week intervention
    Title
    change of constipation-related symptom scores
    Time Frame
    change from baseline constipation-related symptom scores at four-week intervention
    Secondary Outcome Measure Information:
    Title
    Changes in stool short chain fatty acid content
    Time Frame
    change from baseline stool short chain fatty acid content at four-week intervention
    Title
    Changes in gut microbiota
    Time Frame
    change from baseline gut microbiota at four-week intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25386187
    Citation
    Chu H, Zhong L, Li H, Zhang X, Zhang J, Hou X. Epidemiology characteristics of constipation for general population, pediatric population, and elderly population in china. Gastroenterol Res Pract. 2014;2014:532734. doi: 10.1155/2014/532734. Epub 2014 Oct 16.
    Results Reference
    background
    PubMed Identifier
    3608732
    Citation
    Sandler RS, Drossman DA. Bowel habits in young adults not seeking health care. Dig Dis Sci. 1987 Aug;32(8):841-5. doi: 10.1007/BF01296706.
    Results Reference
    background
    PubMed Identifier
    9299672
    Citation
    Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
    Results Reference
    background
    PubMed Identifier
    26276682
    Citation
    Tigchelaar EF, Bonder MJ, Jankipersadsing SA, Fu J, Wijmenga C, Zhernakova A. Gut microbiota composition associated with stool consistency. Gut. 2016 Mar;65(3):540-2. doi: 10.1136/gutjnl-2015-310328. Epub 2015 Aug 14. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16169298
    Citation
    Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5.
    Results Reference
    background
    PubMed Identifier
    11171619
    Citation
    Husebye E, Hellstrom PM, Sundler F, Chen J, Midtvedt T. Influence of microbial species on small intestinal myoelectric activity and transit in germ-free rats. Am J Physiol Gastrointest Liver Physiol. 2001 Mar;280(3):G368-80. doi: 10.1152/ajpgi.2001.280.3.G368.
    Results Reference
    background
    PubMed Identifier
    25099542
    Citation
    Dimidi E, Christodoulides S, Fragkos KC, Scott SM, Whelan K. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2014 Oct;100(4):1075-84. doi: 10.3945/ajcn.114.089151. Epub 2014 Aug 6.
    Results Reference
    result
    PubMed Identifier
    14631461
    Citation
    Koebnick C, Wagner I, Leitzmann P, Stern U, Zunft HJ. Probiotic beverage containing Lactobacillus casei Shirota improves gastrointestinal symptoms in patients with chronic constipation. Can J Gastroenterol. 2003 Nov;17(11):655-9. doi: 10.1155/2003/654907.
    Results Reference
    result

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    Effect of Probiotic on Constipation

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