Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01913665
Other study ID # not defined yet
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 30, 2013
Last updated August 5, 2013
Start date September 2013

Study information

Verified date August 2013
Source Eskisehir Osmangazi University
Contact Makbule Eren, Associate professor
Phone 00902222392979
Email makbule99@yahoo.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- children with functional constipation over 3 years age

- below 18 years of age

Exclusion Criteria:

- Chronic gastrointestinal disease,

- hirschsprung disease,

- celiac disease,

- hypothyroids,

- neurological deficit,

- constipation treatment receiving children will be excluded

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
B.lactis

Inulin

B.Lactis +Inulin

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Outcome

Type Measure Description Time frame Safety issue
Primary to compare defecation frequency between baseline and 4 th week of treatment baseline and 4th week of intervention No
See also
  Status Clinical Trial Phase
Completed NCT04506801 - The Effect of Probiotics on Functional Constipation in the Elderly N/A
Completed NCT04620161 - A Proof of Concept Study of Pradigastat in Patients With Functional Constipation Phase 2
Active, not recruiting NCT02361749 - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation Phase 4
Completed NCT03054805 - The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation Phase 4
Completed NCT01622972 - Mode of Action of Moviprep Phase 4
Completed NCT01348152 - Effect of TU-100 in Patients With Functional Constipation Phase 2
Completed NCT01212146 - Probiotic-enriched Artichoke in Functional Constipation N/A
Completed NCT04231162 - Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation N/A
Not yet recruiting NCT03639142 - Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children Phase 3
Recruiting NCT04918329 - Functional Digestive Disorders Observatory
Completed NCT02592200 - Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women N/A
Completed NCT03707002 - Effect of scFOS on Increase in Stool Frequency in Constipated People N/A
Recruiting NCT06083311 - The Efficacy of a Probiotic for Functional Constipation (FC) N/A
Completed NCT04110145 - Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation Phase 2
Recruiting NCT06196073 - Visceral Osteopathy in Functional Constipation N/A
Completed NCT04026113 - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Phase 3
Completed NCT02359396 - A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics Phase 1
Completed NCT01847950 - Effects of scFOS on Stool Frequency in People With Functionnal Constipation N/A
Recruiting NCT01274793 - Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy Phase 1
Active, not recruiting NCT04166058 - Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Phase 3