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Cannot perform the study due to practical issues
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This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.
Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri DSM17938 | Experimental | Oil drops |
|
| Placebo | Placebo Comparator | Oils drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM17938 | Dietary Supplement | 5 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily average of crying time with L reuteri vs placebo | Daily crying diary | day 7 |
| Daily average of crying time with L reuteri vs placebo | Daily crying diary | Day 14 |
| Daily average of crying time with L reuteri vs placebo | Daily crying diary | Day 21 |
| Daily average of crying time with L reuteri vs placebo | Daily crying diary | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responder vs non-responders | Daily crying | baseline, day 7, 14, 21, 28 |
| Reduction of daily average crying time | Daily crying |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Badriul Hegar, MD, PhD | RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Badriul Hegar | Jakarta | Indonesia |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Placebo | Dietary Supplement | 5 drops of placebo drops |
|
| baseline, day 7, 14, 21, 28 |
| Parents perception of colic severity (Diary) | Diary | baseline, day 7, 14, 21, 28 |
| Parents/Family quality of life (Diary) | Diary | baseline, day 7, 14, 21, 28 |
| Parental satisfactory (Diary) | Diary | baseline, day 7, 14, 21, 28 |