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This study aimed to fill the gaps by comparing the effectiveness of oral lactase enzyme and lactose free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea.
Although it is well understood that oral lactase enzyme can play a pivotal role in hastening recovery due to secondary lactose intolerance in persistent diarrhea, there is limited local data available in this regard. If exogenous oral lactase enzyme is found to be more effective, it would help children receive uninterrupted milk and milk-based diet during the diarrheal episode, as the former would aid digestion and absorption of lactose, thus providing the necessary nutrients especially (calcium) and vitamins so vital in this period of rapid growth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactase enzyme group | Experimental | In this group, 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, was added 5-30 minutes before feeding. |
|
| Lactose-free formula feed group | Experimental | In this group, lactose-free formula milk/diet was advised. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactase enzyme | Dietary Supplement | Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of diarrhea | It was labeled on the basis of frequency of stools ≤ 4 and consistency of stools ≤ 5 (Bristol Stool Chart, ideal range 3-5) | 5 days |
| Reduction in abdominal pain | A score of ≤ 4, assessed on the basis of faces pain score revised chart (FPS-R), was considered as reduction in pain (a higher score indicating more severe pain) | 5 days |
| Lessening in bloating | It was assessed on the basis of a decrease in the abdominal girth (≤ 1) at the umbilicus by a non- stretchable measuring tape | 5 days |
| Resolution of nausea/vomiting no perianal rash or only | Decrease in the frequency of nausea/vomiting | 5 days |
| Resolution of perianal rash | If no perianal rash or only erythema is seen | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment successful | The secondary outcome was treatment success assessed on the basis of all 3 conditions fulfilled, i.e., diarrhea (frequency < 4 stools, consistency < 5) lasting less than 5 days, stool pH > 6, and hospital stays < 5 days. | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatima Ghayas, FCPS | Hamdard University Hospital, Karachi | Principal Investigator |
| Heena Ghayas, FCPS | Ziauddin University Karachi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziauddin University Hospital, Kemari | Karachi | Sindh | 75620 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D043322 | Lactase |
| ID | Term |
|---|---|
| D001616 | beta-Galactosidase |
| D005696 | Galactosidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
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| Lactose-free formula feed | Dietary Supplement | Patients were advised lactose-free formula milk/diet. |
|
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |