Secondary Lactose IntoleranceNCT06827405
Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula
A study testing Lactase enzyme and Lactose-free formula feed in people with Secondary Lactose Intolerance, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Secondary Lactose Intolerance
- What is being tested?
- Lactase enzyme and Lactose-free formula feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula in the Management of Secondary Lactose Intolerance in Persistent and Severe Persistent Diarrhea
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.
Read the 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.
- Conditions
- Secondary Lactose Intolerance
- Being tested
- Lactase enzyme, Lactose-free formula feed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactase enzymeDietary supplement
Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding
Lactose-free formula feedDietary supplement
Patients were advised lactose-free formula milk/diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Lactase enzyme |
| Lactose-free formula feed group | Experimental | In this group, lactose-free formula milk/diet was advised. Receives: Dietary Supplement: Lactose-free formula feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 5 days
Resolution of nausea/vomiting no perianal rash or only
Decrease in the frequency of nausea/vomiting
Measured: 5 days
Resolution of perianal rash
If no perianal rash or only erythema is seen
Measured: 5 days
Secondary outcomes (1)
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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jun 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary Lactose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Fatima Ghayas, FCPS, Principal investigator, Hamdard University Hospital, KarachiHeena Ghayas, FCPS, Study director, Ziauddin University Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827405
- Sponsor's protocol ID
- ZUHKARACHI
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Publications
Siddiqi FG, Rais H, Anwar T, Khan AA. Comparison of the effectiveness of oral lactase enzyme and lactose-free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea. Pak J Med Sci. 2026 Aug;42(8):2123-2128. doi: 10.12669/pjms.42.8.12258.
PubMed 42668931
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula in the Management of Secondary Lactose Intolerance in Persistent and Severe Persistent Diarrhea
- ClinicalTrials.gov ID
- NCT06827405
- Acronym / sponsor ID
- ZUHKARACHI
- Conditions
- Secondary Lactose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactase enzyme group | Experimental | Dietary Supplement: Lactase enzymeIn 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 | Dietary Supplement: Lactose-free formula feedIn this group, lactose-free formula milk/diet was advised. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactase enzymePatients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding | Dietary supplement | Lactase enzyme group |
| Lactose-free formula feedPatients were advised lactose-free formula milk/diet. | Dietary supplement | Lactose-free formula feed group |
Primary outcome
Resolution of diarrhea
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 days
Decrease in the frequency of nausea/vomiting
Resolution of perianal rash
Time frame: 5 days
If no perianal rash or only erythema is seen
1 secondary outcome
Treatment successful
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 42668931Siddiqi FG, Rais H, Anwar T, Khan AA. Comparison of the effectiveness of oral lactase enzyme and lactose-free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea. Pak J Med Sci. 2026 Aug;42(8):2123-2128. doi: 10.12669/pjms.42.8.12258.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Ghayas, FCPS principal investigator
Hamdard University Hospital, Karachi
Heena Ghayas, FCPS study director
Ziauddin University Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactase enzyme and Lactose-free formula feed in people with Secondary Lactose Intolerance, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of diarrhea (time frame: 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.