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| Tracking Information | |||||
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| First Received Date ICMJE | July 7, 2005 | ||||
| Last Updated Date | December 12, 2007 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Growth, as measured by weight for age and height | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00118872 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants | ||||
| Official Title ICMJE | Feasibility Study of Probiotics for Growth Faltering in Pakistan | ||||
| Brief 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. 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: food supplement: Lactobacillus GG | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | January 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 5 Weeks | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | Pakistan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00118872 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21 AT001486-01A2, Wanke 01 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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