The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.

Constipation Clinical Trial

Official title:

The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862341
• Other study ID #: FON-JOLIE-PPH-2012-01
• Status: Completed
• Phase: N/A
• First received: May 10, 2013
• Last updated: August 6, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Fonterra Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• ANMUM In-Shape Nutritional Milk Powder for Active Mothers

Locations

Country	Name	City	State
Philippines	Villamor Air Base	Makati
Philippines	Camp Aguinaldo	Manilla
Philippines	Camp Crame	Quezon
Philippines	Camp Bagong Diwa	Taguig

Sponsors (2)

Lead Sponsor	Collaborator
Fonterra Research Centre	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel improvement	Evaluate the perceptions of selected Filipino women (21-35 years of age) on the effectiveness of milk powder with fiber and probiotics on improving bowel movement through questionnaires.	up to day 28	No
Secondary	Intestinal health	Assess intestinal improvement determined by questionnaire on sensation after bowel movement and state of stools (color, odor, shape) through a questionnaire.	Day 0 and day 28	No
Secondary	General well-being and lifestyle attitudes	Assess the general well-being and lifestyle attitudes through a questionnaire.	Day 3, 7, 10, 14, 21, 24, and 28	No