Secondary Lactose Intolerance
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLactase enzyme
Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding
DIETARY_SUPPLEMENTLactose-free formula feed
Patients were advised lactose-free formula milk/diet.
Sponsors
Muhammad Aamir Latif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Both genders * Aged 6-24 months * Presented with persistent or severe persistent diarrhea due to secondary lactose intolerance * Patients on formula or mixed feeding, or formula/cow/buffalo milk
Exclusion criteria
* Severe acute malnutrition * Hemodynamic instability (shock) * Those on oral antibiotics or on excessive juices * With conditions of malabsorptive states (celiac disease, protein losing enteropathy, or irritable bowel syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of diarrhea | 5 days | It was labeled on the basis of frequency of stools ≤ 4 and consistency of stools ≤ 5 (Bristol Stool Chart, ideal range 3-5) |
| Reduction in abdominal pain | 5 days | 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) |
| Lessening in bloating | 5 days | It was assessed on the basis of a decrease in the abdominal girth (≤ 1) at the umbilicus by a non- stretchable measuring tape |
| Resolution of nausea/vomiting no perianal rash or only | 5 days | Decrease in the frequency of nausea/vomiting |
| Resolution of perianal rash | 5 days | If no perianal rash or only erythema is seen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment successful | 6 days | 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. |
Countries
Pakistan
Outcome results
None listed