Lactulose: Mannitol Test as an Indicator of a Potential Modifier of the Effect of Specialized Nutritious Foods in the Treatment of Moderate Acute Malnutrition in Sierra Leone (P10-122-19)

The objective of the study was to examine whether EED at enrollment modifies the effect of specialized nutritious foods (SNFs) on graduation from a moderate acute malnutrition (MAM) treatment program. This sub-study was nested within a cluster randomized trial of MAM children 6–59 months of age supplemented with one of four SNFs: Super Cereal Plus w/amylase (SC + A), Corn Soy Blend Plus w/oil (CSB + w/oil - referent), Corn Soy Whey Blend w/oil (CSWB w/oil), and Ready to Use Supplementary Food (RUSF). Children with mid-upper arm circumference (MUAC) ≥11.5 cm and <12.5 cm with no clinical complications were enrolled. Children received the study food until they reached MUAC ≥12.5 cm or up to 12 weeks. EED was assessed at enrollment using the lactulose: mannitol (L: M) test. Samples from 387 participants were analyzed. Logistic regression was used to test for effect modification by L: M ratio (LM), L: M excretion ratio (LMER), and % lactulose excreted (%L). At enrollment, the mean ± SD age of sub-study participants was 14.5 ± 9.12 months, 57% were female, and 24% previously had severe acute malnutrition (SAM). The median LM was 0.49 (interquartile range, IQR = 0.42), LMER was 0.10 (IQR = 0.08), and %L was 0.34 (IQR = 0.42). The overall graduation rate was 66% (range: 60% to 74% by food). LMER, LM, and %L did not modify the effect of the study foods in unadjusted models (P = 0.116, P = 0.116, P = 0.176), and models adjusted for age, gender, and previous SAM (P = 0.057, P = 0.057, P = 0.337). Analysis excluding children with watery stool after L: M dosing (N = 16), but not before as reported by the caregiver, showed statistically significant effect modification by LMER (P = 0.03; SC + A vs. CSB + : β = 12.69, P = 0.013) and L: M ratio (P = 0.03, SC + A vs. CSB + : β = 2.55, P = 0.013). In this study we did not find EED (L: M test) at enrollment to modify the effect of SNFs on likelihood of graduation from a MAM treatment program. This may be because EED did not affect graduation from the program, or because EED severity changes over the course of treatment. Watery stool post L: M dosing should be systematically recorded and its effect assessed in analysis. This work was supported by the Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.