Clinical trial NCT01862341: The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
Official title: The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Constipation
Bowel movement
Intestinal health
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2013-05-24
Enrollment: 72
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 health well being in selected Filipino mothers


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Bowel improvement
timeFrame: up to day 28
Secondary outcomes:
measure: Intestinal health
timeFrame: Day 0 and day 28
measure: General well-being and lifestyle attitudes
timeFrame: Day 3, 7, 10, 14, 21, 24, and 28
Other outcomes:
Locations:
city: Makati
country: Philippines
facility: Villamor Air Base
city: Manilla
country: Philippines
facility: Camp Aguinaldo
city: Quezon
country: Philippines
facility: Camp Crame
city: Taguig
country: Philippines
facility: Camp Bagong Diwa
Study officials:
affiliation: FNRI
name: Imelda Agdeppa, PhD
role: PRINCIPAL_INVESTIGATOR
References: