MalnutritionNCT00118872
Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
A study testing LGG yogurt in people with Malnutrition and Diarrhea, run by Tufts University at 1 site in Pakistan.
Trial summary
This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding. Read more about this study
- Who is it for?
- Ages 1 week to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Diarrhea
- What is being tested?
- LGG yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2006to Mar 2008
- 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 1 week to 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born and reside in Bilal Colony, Karachi Pakistan during the study
- Parent or guardian willing to provide informed consent
- Parent or guardian willing to permit home visits
- Predominantly breastfed at study start
Who cannot join
- Malnutrition at time of weaning
- Medical condition that would affect response to LGG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Probiotics for Growth Faltering in Pakistan
This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding.
Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the impact of faltering growth in babies living in the slums of Pakistan.
Read the detailed description
Faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are being weaned from breastfeeding will be given LGG-containing yogurt in this study to determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.
Infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. During the weaning period, participants will be randomly assigned to either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All participants will have height and weight measurements taken at study entry and at Month 3 (study completion). The number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.
- Conditions
- Malnutrition, Diarrhea
- Being tested
- LGG yogurt, Placebo yogurt
- Keywords
- Growth and Development, Pakistan, Weaning, Probiotics, Infant, Lactobacillus GG
- Medical subject headings
- Malnutrition, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGG yogurtDrug
Also called Lactobacillus GG containing yogurt
Lactobacillus GG containing yogurt
Placebo yogurtOther
Yogurt NOT containing the active LGG bacteria
| Study group | Role | What they receive |
|---|---|---|
| LGG yogurt | Active comparator | Lactobacillus (LGG) containing yogurt Receives: Drug: LGG yogurt; Other: Placebo yogurt |
| Placebo yogurt | Placebo comparator | Regular yogurt, NOT containing LGG Receives: Other: Placebo yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth, as measured by weight for age and height
Measured: 3 months
Secondary outcomes (2)
Number of episodes of diarrhea
Measured: 3 months
duration of episodes of diarrhea
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Christine A. Wanke, MD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118872
- Sponsor's protocol ID
- R21AT001486-01A2
- Other IDs
- R21AT001486, Wanke 01
- Status last verified
- Aug 2019
- First submitted
- 7 Jul 2005
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Probiotics for Growth Faltering in Pakistan
- ClinicalTrials.gov ID
- NCT00118872
- Acronym / sponsor ID
- R21AT001486-01A2
- Conditions
- Malnutrition, Diarrhea
- Keywords
- Growth and Development, Pakistan, Weaning, Probiotics, Infant, Lactobacillus GG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Jul 2005 (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.
This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding.
Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the impact of faltering growth in babies living in the slums of Pakistan.
Detailed description
Faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are being weaned from breastfeeding will be given LGG-containing yogurt in this study to determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.
Infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. During the weaning period, participants will be randomly assigned to either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All participants will have height and weight measurements taken at study entry and at Month 3 (study completion). The number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG yogurt | Active comparator | Drug: LGG yogurt, Other: Placebo yogurtLactobacillus (LGG) containing yogurt |
| Placebo yogurt | Placebo comparator | Other: Placebo yogurtRegular yogurt, NOT containing LGG |
Who may qualify
- Ages
- 1 week to 5 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born and reside in Bilal Colony, Karachi Pakistan during the study
- Parent or guardian willing to provide informed consent
- Parent or guardian willing to permit home visits
- Predominantly breastfed at study start
Key exclusion criteria (2 listed)
- Malnutrition at time of weaning
- Medical condition that would affect response to LGG
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 |
|---|---|---|
| LGG yogurtAlso: Lactobacillus GG containing yogurtLactobacillus GG containing yogurt | Drug | LGG yogurt |
| Placebo yogurtYogurt NOT containing the active LGG bacteria | Other | LGG yogurt, Placebo yogurt |
Primary outcome
Growth, as measured by weight for age and height
Time frame: 3 months
2 secondary outcomes
Number of episodes of diarrhea
Time frame: 3 months
duration of episodes of diarrhea
Time frame: 3 months
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 4 Sep 2019.
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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.
Christine A. Wanke, MD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGG yogurt in people with Malnutrition and Diarrhea, run by Tufts University at 1 site in Pakistan.
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 4 inclusion and 2 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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. Some participants in this study may receive a placebo. 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?
Growth, as measured by weight for age and height (time frame: 3 months). 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 4 Sep 2019.