Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-28 @ 2:20 AM
Study NCT ID:
NCT03100851
Status:
COMPLETED
Last Update Posted:
2017-06-29
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic on Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-28', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of stool consistency', 'timeFrame': 'change from baseline stool consistency at four-week intervention'}, {'measure': 'change of defecation frequency', 'timeFrame': 'change from baseline defecation frequency at four-week intervention'}, {'measure': 'change of constipation-related symptom scores', 'timeFrame': 'change from baseline constipation-related symptom scores at four-week intervention'}], 'secondaryOutcomes': [{'measure': 'Changes in stool short chain fatty acid content', 'timeFrame': 'change from baseline stool short chain fatty acid content at four-week intervention'}, {'measure': 'Changes in gut microbiota', 'timeFrame': 'change from baseline gut microbiota at four-week intervention'}]}, 'conditionsModule': {'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '25386187', 'type': 'BACKGROUND', '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.'}, {'pmid': '3608732', 'type': 'BACKGROUND', '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.'}, {'pmid': '9299672', 'type': 'BACKGROUND', '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.'}, {'pmid': '26276682', 'type': 'BACKGROUND', '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.'}, {'pmid': '16169298', 'type': 'BACKGROUND', '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.'}, {'pmid': '11171619', 'type': 'BACKGROUND', '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.'}, {'pmid': '25099542', 'type': 'RESULT', '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.'}, {'pmid': '14631461', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet ROME Ⅲ criteria for functional constipation\n* normal body mass index between 18.5 and 29.9\n\nExclusion Criteria:\n\n* had a serious disease;\n* used systemic antibiotics or antimycotics medication and antidiarrheal or laxative medication in the 30 days prior to the study;\n* allergic to milk protein;\n* constipated because of organic or neurological lesions;\n* participated in any other studies within 2 months prior to this study.'}, 'identificationModule': {'nctId': 'NCT03100851', 'briefTitle': 'Effect of Probiotic on Constipation', 'organization': {'class': 'OTHER', 'fullName': 'China Agricultural University'}, 'officialTitle': 'Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Chinese People With Constipation', 'orgStudyIdInfo': {'id': 'CAUConstipation-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LcS intervention', 'description': 'Patients with constipation received dietary supplement with Lactobacaiilus casei strain Shirota.', 'interventionNames': ['Dietary Supplement: Lactobacillus casei strain Shirota']}], 'interventions': [{'name': 'Lactobacillus casei strain Shirota', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a bottle of 100 mililiter probiotic dairy beverage containing 10\\^8 CFU Lactobacillus casei strain Shirota every day after lunch.', 'armGroupLabels': ['LcS intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Agricultural University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fazheng Ren', 'investigatorAffiliation': 'China Agricultural University'}}}}