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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT001486 | U.S. NIH Grant/Contract | View source | |
| Wanke 01 |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LGG yogurt | Active Comparator | Lactobacillus (LGG) containing yogurt |
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| Placebo yogurt | Placebo Comparator | Regular yogurt, NOT containing LGG |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGG yogurt | Drug | Lactobacillus GG containing yogurt |
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| Measure | Description | Time Frame |
|---|---|---|
| Growth, as measured by weight for age and height | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of diarrhea | 3 months | |
| duration of episodes of diarrhea | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine A. Wanke, MD | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan Medical Center | Karachi | Pakistan |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| Placebo yogurt | Other | Yogurt NOT containing the active LGG bacteria |
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| D013568 | Pathological Conditions, Signs and Symptoms |