Effect of Probiotic on Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100851
• Other study ID #: CAUConstipation-01
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2017
• Last updated: June 28, 2017
• Start date: August 2, 2015
• Est. completion date: March 17, 2017

Study information

• Verified date: June 2017
• Source: China Agricultural University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 17, 2017
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• meet ROME ? 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.

Related Conditions & MeSH terms

• Constipation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Agricultural University

References & 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. Review. — View 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.1 — View Citation

Husebye E, Hellström 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. — View 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. Epub 2005 Oct 5. — View 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. — View 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. — View Citation

Sandler RS, Drossman DA. Bowel habits in young adults not seeking health care. Dig Dis Sci. 1987 Aug;32(8):841-5. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of stool consistency		change from baseline stool consistency at four-week intervention
Primary	change of defecation frequency		change from baseline defecation frequency at four-week intervention
Primary	change of constipation-related symptom scores		change from baseline constipation-related symptom scores at four-week intervention
Secondary	Changes in stool short chain fatty acid content		change from baseline stool short chain fatty acid content at four-week intervention
Secondary	Changes in gut microbiota		change from baseline gut microbiota at four-week intervention