NCT03100851

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

March 29, 2017

Last Update Submit

June 28, 2017

Conditions

Constipation

Outcome Measures

Primary Outcomes (3)

  • change of stool consistency

    change from baseline stool consistency at four-week intervention

  • change of defecation frequency

    change from baseline defecation frequency at four-week intervention

  • change of constipation-related symptom scores

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

Secondary Outcomes (2)

  • Changes in stool short chain fatty acid content

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

  • Changes in gut microbiota

    change from baseline gut microbiota at four-week intervention

Study Arms (1)

LcS intervention

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus casei strain Shirota

Interventions

Lactobacillus casei strain ShirotaDIETARY_SUPPLEMENT

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

LcS intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • meet ROME â…¢ criteria for functional constipation
  • normal body mass index between 18.5 and 29.9

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 25386187BACKGROUND

  • 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.

    PMID: 3608732BACKGROUND

  • 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.

    PMID: 9299672BACKGROUND

  • 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.

    PMID: 26276682BACKGROUND

  • 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.

    PMID: 16169298BACKGROUND

  • 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.

    PMID: 11171619BACKGROUND

  • 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.

    PMID: 25099542RESULT

  • 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.

    PMID: 14631461RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

August 2, 2015

Primary Completion

September 26, 2016

Study Completion

March 17, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06