Cited by 63Digestive system and related healthGastrointestinal motility and disordersDrug Solubulity and Delivery Systems

Low-dose lactose in drugs neither increases breath hydrogen excretion nor causes gastrointestinal symptoms

MONTALTO, M., GALLO, A., SANTORO, L., D’ONOFRIO, F., CURIGLIANO, V., COVINO, M., CAMMAROTA, G., GRIECO, A. +2 more·2008·Alimentary Pharmacology & Therapeutics

Abstract

BACKGROUND: Despite the reported tolerance to a low dose of lactose, many lactose malabsorbers follow a rigorous lactose-free diet also avoiding lactose-containing drugs. Up to now, only a few case reports have described the onset of gastrointestinal symptoms in lactose malabsorbers following the ingestion of these drugs. It has been suggested that capsules/tablets contain no more than 400 mg of lactose. AIM: To evaluate breath H(2) excretion and intolerance symptoms after ingestion of a capsule containing 400 mg of lactose or placebo through a randomized, cross-over, double-blind, controlled study. METHODS: Seventy-seven lactose maldigesters with intolerance underwent two H2 breath tests with both 400 mg of lactose and 400 mg of placebo. Gastrointestinal symptoms occurring in the 8 h following the ingestion of different substrates were evaluated by a visual-analogue scale. RESULTS: Ingestion of 400 mg of lactose did not cause a significant difference in breath H2 excretion or in the severity of gastrointestinal symptoms compared to placebo. CONCLUSION: In patients with lactase deficiency, drugs containing 400 mg of lactose or less can be used safely.

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Crossref · 10.1111/j.1365-2036.2008.03815.x

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34 of 34 references verified0 citation errors · 0 not checkable

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  • Lactose used as an excipient in levothyroxine tablets is unlikely to cause significant problems, since up to 400 mg lactose does not provoke gastrointestinal symptoms.

    “It is unlikely that lactose used as an excipient in LT4 tablets would cause significant problems, as studies show that ingestion of up to 400 mg of lactose does not provoke gastrointestinal symptoms.38,59”

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Authors
MONTALTO, M., GALLO, A., SANTORO, L., D’ONOFRIO, F., CURIGLIANO, V., COVINO, M., CAMMAROTA, G., GRIECO, A., GASBARRINI, A., & GASBARRINI, G.
Affiliations
Università Cattolica del Sacro Cuore (IT)
Corresponding author
MONTALTO, M.
Venue
Alimentary Pharmacology & Therapeutics
Publisher
Wiley
Published
2008-09-20
Volume
28
Issue
8
Pages
1003-1012
ISSN
  • 0269-2813 (ISSN-L)
  • 1365-2036
OpenAlex
W1995717806
Cited by
63
References
34
Citations by year
2026: 2 · 2025: 2 · 2024: 2 · 2023: 5 · 2022: 2 · 2021: 1 · 2020: 3 · 2019: 4 · 2018: 6 · 2017: 7 · 2016: 3 · 2015: 5 · 2014: 3 · 2013: 2 · 2012: 5
FWCI
1.90
Type
journal article
Language
en
Open access
closed
Locations
  • Alimentary Pharmacology & Therapeutics (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Digestive system and related health
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
Keywords
lactose malabsorption, lactose intolerance, breath hydrogen excretion, lactase deficiency, gastrointestinal symptoms
MeSH terms
Adult, Aged, Aged, 80 and over, Breath Tests, Dose-Response Relationship, Drug, Double-Blind Method, Female, Gastrointestinal Diseases, Humans, Hydrogen, Lactose, Lactose Intolerance, Male, Middle Aged, Severity of Illness Index, Statistics as Topic, Abdominal Pain, Cross-Over Studies

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