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Randomised trial · Nutrients · 2024Conflicts declared

Locust bean gum in infant formula and stool consistency

Salvatore S, Klymenko V, Karpushenko Y, et al · Free full text

What it found

In 103 infants with regurgitation, a formula thickened with locust bean gum did not make stools looser or more watery than a formula without it.

The gum-thickened formula also reduced how often the infants brought milk back up.

What they found

Studies in people

Stool consistency

At week 8, the gum-thickened formula was not worse than the control formula for stool consistency. The test group did not have looser or more watery stools.

Hard stools

More hard stools were seen in the test group at weeks 2 and 4, but not at other weeks. No infant had hard stools with two or fewer bowel movements per week.

Regurgitation frequency

Infants on the gum-thickened formula brought up milk less often than those on the control formula at every visit after the start. By week 2, the number of infants with four or more regurgitations a day fell by 86.4% in the test group and 44.5% in the control group.

Gut symptoms

Gut symptom scores improved in both groups over the study, with no difference between them. Scores dropped from about 32 at the start to under 25 by the end.

Growth

Weight, length, weight-for-length and head circumference were similar in both groups and within normal ranges.

Side effects

The number of side effects was similar in both groups. Mild diarrhea and mild flatulence were uncommon, and no constipation was reported.

What the authors conclude

“Both products were well-tolerated and safe and the AR formula with LBG was efficacious in reducing regurgitation frequency.”
Salvatore S, Klymenko V, Karpushenko Y, et al, 2024

Also in their conclusions

  • They conclude that the anti-regurgitation formula with locust bean gum did not lead to more loose or watery stools than the control formula.
  • They state that both products were well-tolerated and safe.
  • They say the study provides further confirmation of a significant beneficial effect of the formula containing locust bean gum on the dietary management of regurgitation in infants who are not exclusively breastfed.

How it was done

Regurgitation is common in infants and often worries parents. The authors ran this trial to support the re-evaluation of the safety of locust bean gum in infant formula, after a request from the European Food Safety Authority.

They randomly assigned 103 full-term infants with regurgitation, aged 21 to 63 days, to an anti-regurgitation formula with locust bean gum or a formula without it, for at least 8 weeks. Parents recorded stool consistency daily, and other symptoms were tracked at study visits.

What it can’t tell you

  • The trial lasted only 8 weeks, so it cannot show what happens over a longer period.
  • The study was not labelled as double-blind because parents might notice the difference in thickness between the formulas.
  • Blood mineral status was only checked in four infants, so no conclusions can be drawn about that.

The paper

Title
Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Pre-, and Postbiotics: A Multi-Country Multi-Center Prospective Randomized Controlled Study in Infants with Regurgitation
Type
Randomised controlled trial
Evidence
Studies in people
Summarised from
Full text
Cite
Salvatore S, Klymenko V, Karpushenko Y, et al (2024). Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Pre-, and Postbiotics: A Multi-Country Multi-Center Prospective Randomized Controlled Study in Infants with Regurgitation. Nutrients. doi:10.3390/nu16060899Free full textPubMed 38542810DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error