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Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial

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Abstract

Background

Oral rehydration therapy is the recommended treatment for acute childhood gastroenteritis. The aim of this study was to assess the efficacy and safety of gelatin tannate plus oral rehydration compared with oral rehydration alone.

Methods

We conducted a multicenter, parallel, randomized, controlled, single-blind, prospective, open-label trial. A central randomization center used computer generated tables to allocate treatments. The study was performed in two medical centers in Italy. Sixty patients 3–72 months of age with acute gastroenteritis were recruited (median age 18 months; age range 3–66 months): 29 received an oral rehydration solution (ORS) and 31 an ORS plus gelatin tannate (ORS + G). The primary outcome was the number of bowel movements 48 and 72 h after initiating treatment. Secondary outcomes were: duration of diarrhea, stool characteristics and adverse events.

Results

No patient was lost at follow-up. No significant difference in the number of bowel movements after 48 h was reported (2.7 ± 1.3 ORS + G; 3.2 ± 0.8 ORS; p = 0.06), although the ORS + G group showed a significant improvement in stool consistency (3.7 ± 1.0 vs. 4.3 ± 0.8; p = 0.005). At 72 h, a significant reduction in bowel movements was reported in the ORS + G group compared with the ORS group (1.0 ± 1.4 vs. 2.0 ± 1.7; p = 0.01). Mean duration of diarrhea was significantly lower in the ORS + G group than in the ORS only group (76.8 ± 19.2 vs. 108 ± 24.0 h; p < 0.0001). No adverse events were reported.

Conclusions

Gelatin tannate added to oral rehydration in children with acute diarrhea was associated with a significant decrease in bowel movements at 72 h, with an early improvement in the stool consistency and shorter disease duration.

Clinical Trial Registration

NCT02644200—Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis (https://www.clinicaltrials.gov).

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Author information

Authors and Affiliations

  1. Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy

    Maurizio Mennini, Salvatore Cucchiara & Marina Aloi

  2. Department of Pediatrics, Second University of Naples, Viale Beneduce 10, 81100, Caserta, Italy

    Carlo Tolone

  3. Department of Pediatrics, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy

    Maurizio Mennini, Antonella Frassanito & Fabio Midulla

Authors
  1. Maurizio Mennini
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  2. Carlo Tolone
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  3. Antonella Frassanito
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  4. Fabio Midulla
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  5. Salvatore Cucchiara
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  6. Marina Aloi
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Corresponding author

Correspondence to Maurizio Mennini.

Ethics declarations

The study protocol was defined in accordance with the Declaration of Helsinki, and was approved by the ethical committee of each participating center (number of protocol 593/12). Written informed consent was obtained from parents of all children.

Conflict of interest

Maurizio Mennini M.D., Carlo Tolone, M.D., Antonella Frassanito M.D., Fabio Midulla M.D. Ph.D., Salvatore Cucchiara M.D. Ph.D. and Marina Aloi M.D., Ph.D. declare that they have no conflict of interest and no financial relationships relevant to this article to disclose.

Funding source

No external funding was received for this manuscript.

Contributors’ statement

Dr. Aloi and Dr Mennini conceptualized and designed the study, drafted the initial manuscript, and approved the final manuscript as submitted. Dr. Tolone and Dr. Mennini allocated and managed enrolled patients. Dr. Aloi and Dr. Frassanito designed the data collection instruments and carried out the initial analyses. Prof. Cucchiara and Prof. Midulla critically reviewed the manuscript and approved the final manuscript as submitted.

Availability of data and materials

Data will not be shared, because of institutional policy. We will, however, be available to share them in the event of a specific request from a reviewer.

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Mennini, M., Tolone, C., Frassanito, A. et al. Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial. Pediatr Drugs 19, 131–137 (2017). https://doi.org/10.1007/s40272-016-0207-z

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  • DOI: https://doi.org/10.1007/s40272-016-0207-z

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