ConstipationNCT01862341
The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
A study testing ANMUM In-Shape Nutritional Milk Powder for Active Mothers in people with Constipation, run by Fonterra Research Centre at 4 sites in Philippines.
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 Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- ANMUM In-Shape Nutritional Milk Powder for Active Mothers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesPhilippines
- Study dates
- May 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Philippines4 sites
Camp Bagong Diwa
City of Taguig
Villamor Air Base
Makati
Camp Aguinaldo
Manila
Camp Crame
Quezon
About this study
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
- Conditions
- Constipation
- Being tested
- ANMUM In-Shape Nutritional Milk Powder for Active Mothers
- Keywords
- Constipation, Bowel movement, Intestinal health
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANMUM In-Shape Nutritional Milk Powder for Active MothersDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Milk powder | Experimental | ANMUM In-Shape Nutritional Milk Powder for Active Mothers. The dose of the milk powder is 40g added to 200ml of drinkable water and will be taken twice a day. Receives: Dietary Supplement: ANMUM In-Shape Nutritional Milk Powder for Active Mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to day 28
Secondary outcomes (2)
Intestinal health
Assess intestinal improvement determined by questionnaire on sensation after bowel movement and state of stools (color, odor, shape) through a questionnaire.
Measured: Day 0 and day 28
General well-being and lifestyle attitudes
Assess the general well-being and lifestyle attitudes through a questionnaire.
Measured: Day 3, 7, 10, 14, 21, 24, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fonterra Research Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Imelda Agdeppa, PhD, Principal investigator, FNRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862341
- Sponsor's protocol ID
- FON-JOLIE-PPH-2012-01
- Status last verified
- Aug 2013
- First submitted
- 10 May 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
- ClinicalTrials.gov ID
- NCT01862341
- Acronym / sponsor ID
- FON-JOLIE-PPH-2012-01
- Conditions
- Constipation
- Keywords
- Constipation, Bowel movement, Intestinal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fonterra Research CentreIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milk powder | Experimental | Dietary Supplement: ANMUM In-Shape Nutritional Milk Powder for Active MothersANMUM In-Shape Nutritional Milk Powder for Active Mothers. The dose of the milk powder is 40g added to 200ml of drinkable water and will be taken twice a day. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANMUM In-Shape Nutritional Milk Powder for Active Mothers | Dietary supplement | Milk powder |
Primary outcome
Bowel improvement
Time frame: up to day 28
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.
2 secondary outcomes
Intestinal health
Time frame: Day 0 and day 28
General well-being and lifestyle attitudes
Time frame: Day 3, 7, 10, 14, 21, 24, and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imelda Agdeppa, PhD principal investigator
FNRI
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANMUM In-Shape Nutritional Milk Powder for Active Mothers in people with Constipation, run by Fonterra Research Centre at 4 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel improvement (time frame: up to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.