Status:
COMPLETED
The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
Lead Sponsor:
Fonterra Research Centre
Collaborating Sponsors:
Sprim Advanced Life Sciences
Conditions:
Constipation
Eligibility:
FEMALE
21-35 years
Phase:
NA
Brief Summary
In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics and other nutrients. This study will focus on the effects of fiber and probiotics on digestive health and he...
Eligibility Criteria
Inclusion
- Female between 21 and 35 years of age.
- Has at least one child under the age of three.
- Willingness and ability to participate in the study.
- Suffering from mild to moderate constipation and bowel troubles, and non-specific symptoms including bloating, flatulence, gurgling, feeling heavy after eating, and abdominal pain.
- Slow transit or irregular bowels movements (stool consistency harder than usual or fewer bowel movements, i.e. every 2-3 days or less than 3 bowel movements per week).
- Agree to maintain dietetic measures (on their own volition or as previously recommended by health/nutrition professionals), if any, during the study period.
- Subject, or subject's legally acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local Ethics Committee/Institutional Review Board authorization prior to any participation in the study.
Exclusion
- Having participated in another trial currently and up to two months prior to this trial date.
- Known chronic constipation.
- Treated gastrointestinal symptoms.
- Regular intake of laxatives or other remedies to promote digestion (herbal teas, peppermint etc.) during the two weeks before the start of the study or during the study.
- Consuming dairy products or supplements containing Probiotics (e.g., yogurt, Lactic acid drink, drinkable yogurt, food supplements, extracts), Prebiotics (e.g., Oligosaccharides), or fiber supplements within 10 days prior to the start of the study or during the study.
- Currently taking (and during the past 3 months) any dietary fiber supplementation except from food sources.
- Previous contraindication to fiber supplement (Crohn's disease).
- Recently or currently on antibiotic medication in the past two weeks.
- Known allergy to milk proteins or intolerance to lactose.
- Currently pregnant.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01862341
Start Date
May 1 2013
End Date
July 1 2013
Last Update
August 7 2013
Active Locations (4)
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1
Camp Bagong Diwa
City of Taguig, Philippines
2
Villamor Air Base
Makati, Philippines
3
Camp Aguinaldo
Manila, Philippines
4
Camp Crame
Quezon, Philippines