Severe Acute MalnutritionSAM-RICENCT07070856
Trial of Rice-Based F-75 in Severe Malnutrition & Persistent Diarrhea in Children (SAM-RICE Study)
A study testing WHO-recommended standard therapeutic milk used for stabilization phase in SAM) and HO-recommended Rice based therapeutic milk used for stabilization phase in SAM) in people with Severe Acute Malnutrition and Persistent Diarrhea, run by Children's Hospital and Institute of Child Health, Multan at 2 sites in Pakistan.
Trial summary
The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, Persistent Diarrhea, Children
- What is being tested?
- WHO-recommended standard therapeutic milk used for stabilization phase in SAM) and HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesPakistan
- Study dates
- 31 Dec 2024to 31 May 2025
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All the children admitted to the hospital with complaints of persistent diarrhea
- secondary lactose
Who cannot join
- All the children with primary lactose intolerance
- Those parents /guardians refused permission to participate in the study.
- Critically ill child admitted to ICUs and emergency department.
- Patients started therapeutic feeding prior to recruitment in study .
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Tehsil Head Quater Sujah Abad
Multan Khurd, Punjab Province, 60000
The Childrens Hospital and Instotute of Child Health Multan
Multan Khurd, Punjab Province, 60000
About this study
Official title: Efficacy and Safety of Therapeutic Rice Based F75 In Severely Acute Malnourished Children With Persistent Diarrhea.;A Randomized Control Trial.
The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75.
The main questions it aims to answer are:
Read more
- Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?
- Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75?
Researchers will compare two groups:
One group will receive the new rice-based F-75. The other group will receive the standard F-75.
Participants will:
- Be children aged 6 to 59 months admitted with SAM and persistent diarrhea
- Be randomly assigned to one of the two feeding groups
- Stay in a hospital ward for monitoring during the stabilization phase
Be assessed daily for:
Stool frequency Weight changes Appetite Medical problems or side effects
This study will help determine whether the rice-based F-75 is a better option for malnourished children with diarrhea.
Read the detailed description
Persistent diarrhea in children with severe acute malnutrition (SAM) poses a significant clinical challenge, particularly during the stabilization phase. Standard therapeutic protocols include the use of F-75-a milk-based formula designed to meet the reduced metabolic demands of severely malnourished children. However, lactose content in milk-based F-75 may exacerbate intestinal symptoms in children with secondary lactase deficiency, commonly observed in cases of persistent diarrhea.
Rice-based therapeutic formulations have emerged as promising alternatives, potentially offering superior gastrointestinal tolerance, improved nutrient absorption, and reduced osmolarity compared to conventional milk-based F-75. Rice is hypoallergenic, low in anti-nutritional factors, and contains resistant starches that may support gut integrity and microbial balance during intestinal recovery.
Introducing rice-based F-75 may address dietary intolerance in children with diarrhea-induced lactase deficiency, particularly in low-resource settings where commercial lactose-free preparations are unavailable or unaffordable. This trial seeks to assess whether therapeutic feeding with rice-based F-75 leads to faster stabilization without compromising metabolic safety or nutritional adequacy.Participants are randomized into intervention and control arms during hospitalization, receiving either rice-based or conventional F-75 during the stabilization phase. Transition to F-100 occurs per clinical criteria once acute symptoms resolve.
Clinical monitoring includes:
- Gastrointestinal Tolerance: Stool frequency, consistency, abdominal distension, emesis, and need for additional rehydration.
- Metabolic Safety: Serum sodium, potassium, bicarbonate, and creatinine levels evaluated at baseline and mid-stabilization.
- Nutritional Stabilization: Daily weight, mid-upper arm circumference (MUAC), and feeding tolerance.
- Adverse Events Surveillance: Identification of allergic responses, metabolic complications, or mortality.
- Conditions
- Severe Acute Malnutrition, Persistent Diarrhea, Children
- Being tested
- WHO-recommended standard therapeutic milk used for stabilization phase in SAM), HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)
- Keywords
- Severe Acute Malnutrition, Persistent Diarrhea, F-75 Formula, Rice-Based Diet, Nutritional Rehabilitation, Protein-Energy Malnutrition, Lactose intolerance
- Medical subject headings
- Severe Acute Malnutrition, Protein-Energy Malnutrition, Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO-recommended standard therapeutic milk used for stabilization phase in SAM)Dietary supplement
Also called Stabalization phase feed
F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.
HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)Dietary supplement
Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| WHO standard f75 | Active comparator | standard ,prepared.powdered F75 by WHO Receives: Dietary Supplement: WHO-recommended standard therapeutic milk used for stabilization phase in SAM) |
| Rice Based F75 | Experimental | Rice based F75 BY WHO recipe for PERSISTENT Diarhea Receives: Dietary Supplement: HO-recommended Rice based therapeutic milk used for stabilization phase in SAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stool frequency
episodes of loose stools per day
Measured: day 1 to day 7 of starting therapeutic feed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start31 Dec 2024
- Primary completion31 May 2025
- Study completion31 May 2025
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 Severe Acute MalnutritionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Saadia Khan, Children's Hospital and Institute of Child Health, Multan
- Investigators
- Muhammad T Sultan, PhD, Study chair, Bahauddin zakariya University,Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070856
- Sponsor's protocol ID
- U1111-1324-6540
- Acronym
- SAM-RICE
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Facioni MS, Raspini B, Pivari F, Dogliotti E, Cena H. Nutritional management of lactose intolerance: the importance of diet and food labelling. J Transl Med. 2020 Jun 26;18(1):260. doi: 10.1186/s12967-020-02429-2.
PubMed 32590986
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Therapeutic Rice Based F75 In Severely Acute Malnourished Children With Persistent Diarrhea.;A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07070856
- Acronym / sponsor ID
- SAM-RICE / U1111-1324-6540
- Conditions
- Severe Acute Malnutrition, Persistent Diarrhea, Children
- Keywords
- Severe Acute Malnutrition, Persistent Diarrhea, F-75 Formula, Rice-Based Diet, Nutritional Rehabilitation, Protein-Energy Malnutrition, Lactose intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 17 Jul 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.
The goal of this study is to find out if a rice-based version of the F-75 therapeutic food helps children with severe acute malnutrition (SAM) and persistent diarrhea recover better than the standard commercial F-75.
The main questions it aims to answer are:
- Does rice-based F-75 reduce the duration of diarrhea and improve nutritional recovery in children with SAM?
- Is rice-based F-75 as safe and well-tolerated as the standard WHO F-75?
Researchers will compare two groups:
One group will receive the new rice-based F-75. The other group will receive the standard F-75.
Participants will:
- Be children aged 6 to 59 months admitted with SAM and persistent diarrhea
- Be randomly assigned to one of the two feeding groups
- Stay in a hospital ward for monitoring during the stabilization phase
Be assessed daily for:
Stool frequency Weight changes Appetite Medical problems or side effects
This study will help determine whether the rice-based F-75 is a better option for malnourished children with diarrhea.
Detailed description
Persistent diarrhea in children with severe acute malnutrition (SAM) poses a significant clinical challenge, particularly during the stabilization phase. Standard therapeutic protocols include the use of F-75-a milk-based formula designed to meet the reduced metabolic demands of severely malnourished children. However, lactose content in milk-based F-75 may exacerbate intestinal symptoms in children with secondary lactase deficiency, commonly observed in cases of persistent diarrhea.
Rice-based therapeutic formulations have emerged as promising alternatives, potentially offering superior gastrointestinal tolerance, improved nutrient absorption, and reduced osmolarity compared to conventional milk-based F-75. Rice is hypoallergenic, low in anti-nutritional factors, and contains resistant starches that may support gut integrity and microbial balance during intestinal recovery.
Introducing rice-based F-75 may address dietary intolerance in children with diarrhea-induced lactase deficiency, particularly in low-resource settings where commercial lactose-free preparations are unavailable or unaffordable. This trial seeks to assess whether therapeutic feeding with rice-based F-75 leads to faster stabilization without compromising metabolic safety or nutritional adequacy.Participants are randomized into intervention and control arms during hospitalization, receiving either rice-based or conventional F-75 during the stabilization phase. Transition to F-100 occurs per clinical criteria once acute symptoms resolve.
Clinical monitoring includes:
- Gastrointestinal Tolerance: Stool frequency, consistency, abdominal distension, emesis, and need for additional rehydration.
- Metabolic Safety: Serum sodium, potassium, bicarbonate, and creatinine levels evaluated at baseline and mid-stabilization.
- Nutritional Stabilization: Daily weight, mid-upper arm circumference (MUAC), and feeding tolerance.
- Adverse Events Surveillance: Identification of allergic responses, metabolic complications, or mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO standard f75 | Active comparator | Dietary Supplement: WHO-recommended standard therapeutic milk used for stabilization phase in SAM)standard ,prepared.powdered F75 by WHO |
| Rice Based F75 | Experimental | Dietary Supplement: HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)Rice based F75 BY WHO recipe for PERSISTENT Diarhea |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All the children admitted to the hospital with complaints of persistent diarrhea
- secondary lactose
Key exclusion criteria (4 listed)
- All the children with primary lactose intolerance
- Those parents /guardians refused permission to participate in the study.
- Critically ill child admitted to ICUs and emergency department.
- Patients started therapeutic feeding prior to recruitment in study .
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 |
|---|---|---|
| WHO-recommended standard therapeutic milk used for stabilization phase in SAM)Also: Stabalization phase feedF75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days. | Dietary supplement | WHO standard f75 |
| HO-recommended Rice based therapeutic milk used for stabilization phase in SAM)Rice based F75 GIVEN INITIALLY 2HOURLY,130 ml per kg than 3 and 4hourly maximum takes 5 to 7 days. | Dietary supplement | Rice Based F75 |
Primary outcome
stool frequency
Time frame: day 1 to day 7 of starting therapeutic feed
episodes of loose stools per day
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 24 Aug 2025.
- Background: PubMed 32590986Facioni MS, Raspini B, Pivari F, Dogliotti E, Cena H. Nutritional management of lactose intolerance: the importance of diet and food labelling. J Transl Med. 2020 Jun 26;18(1):260. doi: 10.1186/s12967-020-02429-2.
- Individual participant dataSharing planned: No
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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.
Muhammad T Sultan, PhD study chair
Bahauddin zakariya University,Multan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO-recommended standard therapeutic milk used for stabilization phase in SAM) and HO-recommended Rice based therapeutic milk used for stabilization phase in SAM) in people with Severe Acute Malnutrition and Persistent Diarrhea, run by Children's Hospital and Institute of Child Health, Multan at 2 sites 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 2 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
stool frequency (time frame: day 1 to day 7 of starting therapeutic feed). 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 NCT07070856, 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 24 Aug 2025.