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Table 1 Inclusion/exclusion criteria of the study participants

From: Developing shelf-stable Microbiota Directed Complementary Food (MDCF) prototypes for malnourished children: study protocol for a randomized, single-blinded, clinical study

Inclusion

Parent(s) willing to sign consent form

Child aged 8–12 months

WLZ score < -2 to -3 without bilateral pedal edema at the time of randomization

Parent(s) willing to bring the child to the feeding centre according to the pre-defined schedule

Exclusion

Meeting any of the following criteria will exclude a subject from study participation –

Medical conditions: Malnourished children with complications requiring acute phase treatment in a hospital, children with tuberculosis (diagnosis based on WHO 2014 guidelines which have been incorporated in the national TB control guidelines of Bangladesh). The guidelines depend upon the following five diagnostic principles (three out of five should be positive):

• Specific symptoms of TB

• Specific signs of TB

• Chest X-ray

• Mantoux test

• History of contact

Any congenital/acquired disorder affecting growth, i.e., known case of trisomy-21 or cerebral palsy; children on an exclusion diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy

Severe anemia (< 8 mg/dl)

Antibiotic use (within last 15 days before the onset of intervention)

Ongoing maternal antibiotic usage for breastfeeding infants

Receiving concurrent treatment for another condition