The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.

Official Title
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The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Probiotics fermented milk
* Dietary Supplement: Nutrient drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with functional constipation based on ROME II criteria Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005) Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period Exclusion Criteria: Body Mass Index of less than 16, or 30 and above Pregnant Regular ingestion of probiotic products within the preceding four weeks Regular use of laxatives (average once a week or more) Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month Persons with milk protein allergy Persons with constipation of organic or neurological origin based on health screening Persons with alarm features as assessed by physician during health screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Nutrient drink<br> | Dietary Supplement: Nutrient drink<br>* 80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks<br>|
| Experimental: Probiotics<br> | Dietary Supplement: Probiotics fermented milk<br>* 80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005) | Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation: Severity of false alarms Frequency of less than 3 defecations / week Severity of sensation of incomplete bowel movement Severity of lumpy or hard stools Severity of bloating Frequency of laxative use | 4 weeks | 
| Frequency of bowel movement |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency based on modified Bristol Stool scale | Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5. | 4 weeks | 
| Stool output quantity estimations | Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional constipation, Probiotic, Probiotic microorganism, Lactobacillus casei Shirota (LcS)