ABSTRACT
OBJECTIVE: To determine whether administration of Lactobacillus reuteri DSM 17938 is beneficial in functional abdominal pain (FAP) of childhood. STUDY DESIGN: A total of 101 children, aged 6-15 years, who fulfilled the Rome III criteria for FAP were enrolled in a randomized double-blind, placebo-controlled trial, and were randomly assigned to receive either L reuteri DSM 17938 or placebo for 4 weeks, with further follow-up of additional 4 weeks. Response to therapy was based on a self-reported daily questionnaire monitoring frequency and intensity of abdominal pain, using the faces scoring system by Hicks. RESULTS: L reuteri (n = 47) was significantly superior to placebo (n = 46) in relieving frequency (1.9 ± 0.8 vs 3.6 ± 1.7 episodes/wk, P < .02) and intensity (4.3 ± 2.2 vs 7.2 ± 3.1 Hicks score/wk, P < .01) of abdominal pain following 4 weeks of supplementation. There was no difference in school absenteeism rate or other gastrointestinal symptoms, except for a lower incidence of perceived abdominal distention and bloating, favoring L reuteri. CONCLUSIONS: L reuteri DSM 17938, compared with placebo, significantly reduced the frequency and intensity of FAP in children. TRIAL REGISTRATION: ClicalTrials.gov: NCT01180556.
Subject(s)
Abdominal Pain/drug therapy , Gastrointestinal Diseases/drug therapy , Limosilactobacillus reuteri , Probiotics/therapeutic use , Abdominal Pain/diagnosis , Abdominal Pain/etiology , Absenteeism , Adolescent , Child , Double-Blind Method , Female , Gastrointestinal Diseases/complications , Gastrointestinal Diseases/diagnosis , Humans , Male , Pain Measurement , Prospective Studies , Self Report , Treatment OutcomeABSTRACT
BACKGROUND: The objectives of this trial were to test for noninferiority of a virosomal hepatitis A virus (HAV) vaccine (Epaxal) coadministered with routine childhood vaccines compared with Epaxal given alone and to an alum-adjuvanted HAV vaccine (Havrix Junior) coadministered with routine childhood vaccines. METHODS: Healthy children 12- to 15-month-old were randomized to receive either a pediatric dose (0.25 mL) of Epaxal coadministered with DTPaHibIPV, oral polio vaccine, and measles-mumps-rubella vaccine (n = 109; group A), or Epaxal given alone (n = 105; group B), or Havrix Junior coadministered with DTPaHibIPV, oral polio vaccine, and measles-mumps-rubella vaccine (n = 108; group C). A booster dose was given 6 months later. Anti-HAV antibodies were tested before and 1 month after each vaccination. Safety was assessed for 1 month after each vaccination. Solicited adverse events were assessed for 4 days after each vaccination. RESULTS: : HAV seroprotection rates (> or =20 mIU/mL) at 1 and 6 months after first dose were: A: 94.2% and 87.5%, B: 92.6% and 80.0%, C: 78.2% and 71.3%, respectively (A versus C: P < 0.001 and P = 0.017 at month 1 and 6, respectively). The respective geometric mean concentrations were: A: 51 and 64 mIU/mL, B: 49 and 59 mIU/mL, C: 33 and 37 mIU/mL (A versus C: P < 0.001 at both time points). All groups achieved 100% seroprotection after the booster dose. The geometric mean concentrations after the booster dose were 1758, 1662, and 1414, for groups A, B and C, respectively (A versus C: P = 0.15). No clinically significant reduction in immune response to all concomitant vaccine antigens was seen. All vaccines were well tolerated. CONCLUSIONS: : Coadministration of pediatric Epaxal with routine childhood vaccines showed immunogenicity and safety equal to Epaxal alone as well as to Havrix Junior. After first dose, Epaxal was significantly more immunogenic than Havrix Junior.
