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Effect of Probiotic on Constipation

NCT ID: NCT03100851

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-02

Study Completion Date

2017-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LcS intervention

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

Group Type EXPERIMENTAL

Lactobacillus casei strain Shirota

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Lactobacillus casei strain Shirota

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Agricultural University

OTHER

Sponsor Role lead

Responsible Party

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Fazheng Ren

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 25386187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3608732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9299672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26276682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16169298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11171619 (View on PubMed)

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.

Reference Type RESULT
PMID: 25099542 (View on PubMed)

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.

Reference Type RESULT
PMID: 14631461 (View on PubMed)

Other Identifiers

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CAUConstipation-01

Identifier Type: -

Identifier Source: org_study_id