Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation

Study Overview
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Brief Summary
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Background and aims:Constipation is a frequent complaint and the combination of a prebiotic and probiotics would have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation. Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Expect that patients who took a combination of polydextrose has a decrease in the colonic transit time (CTT) when comparing initial and final transit time.

Official Title
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Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chonic constipation agachan between 10 and 20 bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5 Exclusion Criteria: Patients with hypothyroidism antidepressant users normal colonic transit time (24 hrs or less) as well as higher than 96 hours were

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513) 1 time per day, for 30 days. | Dietary Supplement: yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019<br>* NCFM Group<br>* Other names: lactis HN019 (AGAL NM97/09513);|
| Placebo Comparator: Placebol group<br>regular yogurt, 1 time per day for 30 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic transit |  | Colonic transit time and Agachan score will be evaluated before and in day15 aftler yogurt ingestion. All particIpants will be followed for 30 days after the end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic constipation, Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019