The effect of rice-based, lactose-free F-75 therapeutic formula on diarrhoea in the treatment of children with severe acute malnutrition

The effect of modified F-75 on diarrhoea in the treatment of children with severe acute malnutrition – a randomized controlled 2x2 factorial trial in Uganda

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98124592

Enrollment

450

Registered

2017-08-15

Start date

2017-08-16

Completion date

Unknown

Last updated

2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute malnutrition (SAM) Nutritional, Metabolic, Endocrine Malnutrition

Interventions

Four study arms will receive modified F-75 as a replacement of standard F-75. F-75 is a therapeutic food used during stabilization of hospitalized children with severe acute malnutrition. Randomisatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 6 – 59 months 2. Children with severe acute malnutrition (MUAC < 11.5 cm or weight-for-height z-score < -3 SD or bipedal pitting oedema) 3. Indication for in-patient treatment (oedema above the knees (grade +++)), or failing an appetite test, or medical complications requiring hospitalization 4. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Obvious disability and congenital diseases which may affect eating capabilities 2. Weight below 3.0 kg at admission 3. Malignant diseases 4. Patients participating in another study that may interfere with the current study 5. Patients started on F-75 treatment more than 18 hours before recruitment to the study

Design outcomes

Primary

Measure	Time frame
Number of days with diarrhoea during treatment with modified F-75, measured using a validated stool diary daily from admission to transition	—

Secondary

Measure	Time frame
1. Number of days with diarrhoea during hospitalization, measured using a validated stool diary daily from admission to discharge 2. Incidence of diarrhoea, defined as the proportion of children with minimum one day of diarrhoea, measured at transition and discharge 3. Severity of diarrhoea, assessed using the Vesikari scale daily 4. Consumption and feeding patterns: 4.1. Food intake in ml and duration of the meal measured as 3 time categories daily from admission to transition 4.2. Acceptability using a 5-point hedonic scale on day 2 and at transition 5. Number of days of the first stabilization phase and total number of days spent in the stabilization phase if the child deteriorates and resumes stabilization treatment. Duration of the first stabilization period is defined as: total number of days from admission to the day the child is considered stabilized for the first time. Total number of days spent in stabilization is defined as the total number of days whereby a child is “in the stabilization phase”. It includes the first stabilization phase and any periods when the child may go back to the stabilization phase due to deterioration of health. A child is considered to be stabilized when all these criteria are fulfilled: 1) Return of appetite; the child easily finishes all the prescribed feeds of F-75 and demands for more; 2) Reduced or minimal bilateral pitting oedema (reduced to grade 2 or grade 1); 3) Medical complications resolving; the child may also smile at this stage. 6. Number of days of hospital stay, calculated from the day of admission to discharge. Both days are included in hospitalization duration 7. Plasma electrolyte concentrations (P, Mg, K, Na, Cl, bicarbonate) measured at admission, two days after admission and at transition 8. Degree of dehydration (no, some, severe dehydration and shock), assessed at	—

Measure

Time frame

1. Number of days with diarrhoea during hospitalization, measured using a validated stool diary daily from admission to discharge 2. Incidence of diarrhoea, defined as the proportion of children with minimum one day of diarrhoea, measured at transition and discharge 3. Severity of diarrhoea, assessed using the Vesikari scale daily 4. Consumption and feeding patterns: 4.1. Food intake in ml and duration of the meal measured as 3 time categories daily from admission to transition 4.2. Acceptability using a 5-point hedonic scale on day 2 and at transition 5. Number of days of the first stabilization phase and total number of days spent in the stabilization phase if the child deteriorates and resumes stabilization treatment. Duration of the first stabilization period is defined as: total number of days from admission to the day the child is considered stabilized for the first time. Total number of days spent in stabilization is defined as the total number of days whereby a child is “in the stabilization phase”. It includes the first stabilization phase and any periods when the child may go back to the stabilization phase due to deterioration of health. A child is considered to be stabilized when all these criteria are fulfilled: 1) Return of appetite; the child easily finishes all the prescribed feeds of F-75 and demands for more; 2) Reduced or minimal bilateral pitting oedema (reduced to grade 2 or grade 1); 3) Medical complications resolving; the child may also smile at this stage. 6. Number of days of hospital stay, calculated from the day of admission to discharge. Both days are included in hospitalization duration 7. Plasma electrolyte concentrations (P, Mg, K, Na, Cl, bicarbonate) measured at admission, two days after admission and at transition 8. Degree of dehydration (no, some, severe dehydration and shock), assessed at

—

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026