Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Pediatr. Feb 8, 2016; 5(1): 118-127
Published online Feb 8, 2016. doi: 10.5409/wjcp.v5.i1.118
Effects of carob-bean gum thickened formulas on infants’ reflux and tolerance indices
Miglena Georgieva, Yannis Manios, Niya Rasheva, Ruzha Pancheva, Elena Dimitrova, Anne Schaafsma
Miglena Georgieva, Niya Rasheva, Elena Dimitrova, Second Pediatric Clinic, University Hospital ”St. Marine”, 9000 Varna, Bulgaria
Yannis Manios, Department of Nutrition and Dietetics, Harokopio University of Athens, 17671 Kallithea, Athens, Greece
Ruzha Pancheva, Department of Hygiene, Medical University, 9000 Varna, Bulgaria
Anne Schaafsma, Friesland Campina, Stationsplein 4, 3800 BN Amersfoort, the Netherlands
Author contributions: Georgieva M and Schaafsma A conceived and designed the research; Georgieva M, Rasheva N, Pancheva R and Dimitrova E conducted the research; Georgieva M, Manios Y and Schaafsma A conducted the literature review; Manios Y lead the statistical analyses with the contribution and input from all authors; all authors took part in writing and revising the manuscript.
Supported by A research grant from FrieslandCampina.
Institutional review board statement: The study was reviewed and approved by the Medical Ethical Committee of the “St. Marina” University Hospital of Varna (Ethical approval No. 13/03.28.2013) and was implemented in accordance to the signed protocol and the rules for good clinical practice.
Clinical trial registration statement: The study is registered at http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4334. The registration identification number is NTR4334.
Informed consent statement: Written informed consent was obtained from the parents of all infants that were found to be eligible to be included in the study, prior to study enrollment.
Conflict-of-interest statement: Anne Schaafsma works for Friesland Campina. None of the other authors has any conflicts of interest to declare.
Data sharing statement: No further data is available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Miglena Georgieva, MD, PhD, Associate Professor, Second Pediatric Clinic, University Hospital ”St. Marine”, 1 Christo Smirnenski Avenue, 9000 Varna, Bulgaria. mgeorgieva7@yahoo.com
Telephone: +359-89-9074268 Fax: +359-52-302874
Received: July 14, 2015
Peer-review started: July 17, 2015
First decision: October 21, 2015
Revised: November 4, 2015
Accepted: November 10, 2015
Article in press: November 10, 2015
Published online: February 8, 2016
Processing time: 197 Days and 17.6 Hours
Abstract

AIM: To examine the effect of carob-bean gum (CBG) thickened-formulas on reflux and tolerance indices in infants with gastro-esophageal reflux (GER).

METHODS: Fifty-six eligible infants (1-6 mo old) were randomly allocated to receive for two weeks a formula with either 0.33 g/100 mL (Formula A) or 0.45 g/100 mL (Formula B) of cold soluble CBG galactomannans respectively, or a formula with 0.45 g/100 mL of hot soluble CBG galactomannans (Formula C). No control group receiving standard formula was included in the study. Data on the following indices were obtained both at baseline and follow-up from all study participants: 24 h esophageal pH monitoring indices, anthropometrical indices (i.e., body weight and length) and tolerance indices (i.e., frequency of colics; type and frequency of defecations). From the eligible infants, forty seven were included in an intention-to-treat analysis to examine the effects of the two-week trial on esophageal 24 h pH monitoring, growth and tolerance indices. Repeated Measures ANOVA was used to examine the research hypothesis.

RESULTS: Regarding changes in 24 h pH monitoring indices, significant decreases from baseline to follow-up were observed in the “Boix Ochoa Score” (i.e., an index of esophageal acid exposure), in the total number of visible refluxes and in all symptoms related indices due to acid reflux only for infants provided with Formula A, while no significant changes were observed for infants provided with Formulas B and C. In addition, the significant decreases observed in two symptoms related pH monitoring indices (i.e., “Symptom index for reflux” and “Percentage of all reflux”) for infants provided with Formula A were also found to differentiate significantly compared to the changes observed in the other two groups (P = 0.048 and P = 0.014 respectively). Concerning changes in anthropometric indices, body weight significantly increased among infants provided with Formulas A and C, but not for infants provided with Formula B. As far as tolerance indices were concerned, the numbers of total and diarrheic defecations increased significantly only in infants provided with Formula B and these changes were significantly higher compared to the decreases observed in infants fed with Formulas A and C (P = 0.003 and P = 0.015 respectively. Lastly the number of colics significantly decreased in all infants, irrespective of the tested formula.

CONCLUSION: Formula A (i.e., 0.33 g/100 mL of cold galactomannans) was effective in reducing certain pH-monitoring indices of uncomplicated GER, increased body weight and was well-tolerated by infants.

Keywords: Reflux; Carob bean gum; Galactomannans; Infants; Formula

Core tip: The present study showed that Formula A was more effective in decreasing esophageal acid exposure, the total daily number of visible and measurable refluxes, as well as acid reflux related symptoms, while such changes were not observed for the infants fed with Formulas B and C. Furthermore, a significant increase of body weight was observed for infants fed with Formulas A and C while that was not observed for infants fed with Formula B, probably due to the increased number of diarrheic and total defecations recorded in this group. These findings indicate that Formula A, containing 0.33 g/100 mL of cold soluble galactomannans, seems to be more effective in reducing certain pH-monitoring indices of uncomplicated gastro-esophageal reflux, increasing body weight and being well-tolerated by infants.