Low-dose lactose in drugs neither increases breath hydrogen excretion nor causes gastrointestinal symptoms
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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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”
From Refractory hypothyroidism: unraveling the complexities of diagnosis and management (2023) · cites this paper as [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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