Phase IV noninferiority controlled randomized trial to evaluate the impact on diagnostic thinking and patient management and the test–retest reproducibility of the Gaxilose test for hypolactasia diagnosis

Monsalve-Hernando, Carmen; Crespo, Laura Varela; Ferreiro, Blanca; Martín, V. López; Aldeguer, Xavier; Opio, Verónica; Fernández-Gil, Pedro; Gaspar, M J; Romero, Eduardo; Lara, Carmen; Santander, Cecilio; Torrealba, Leyanira; Savescu, Theodora; Hermida, Carmen

doi:10.1097/md.0000000000013136

Cited by 6 publications

(4 citation statements)

References 22 publications

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“…The key limitation of tests that detect the genetic predisposition to carbohydrate malabsorption (e.g., lactase non‐persistence), the deficiency of certain enzymes required for carbohydrate digestion (e.g., endoscopic biopsy for duodenal hypolactasia), or the presence of specific biomarkers (e.g., gaxilose test 102 ) is that carbohydrate malabsorption is not in itself pathological or even unusual in normal, healthy individuals 68 . In most cases, carbohydrate malabsorption is clinically relevant only if it causes abdominal symptoms (intolerance).…”

Section: Carbohydrate Malabsorption and Intolerancementioning

confidence: 99%

European guideline on indications, performance, and clinical impact of hydrogen and methane breath tests in adult and pediatric patients: European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Neurogastroenterology and Motility, and European Society for Paediatric Gastroenterology Hepatology and Nutrition consensus

et al. 2021

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Section: Carbohydrate Malabsorption and Intolerancementioning

confidence: 99%

European guideline on indications, performance, and clinical impact of hydrogen and methane breath tests in adult and pediatric patients: European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Neurogastroenterology and Motility, and European Society for Paediatric Gastroenterology Hepatology and Nutrition consensus

et al. 2021

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“…This was a noninferiority trial [ 17 ], intended to prove that the efficacy of BC dressing was not inferior to that of the VG dressing in the management of second-degree burn wounds or partial-thickness skin graft donor sites. Hence, the ratio of participants between the two treatments was predetermined as 1:1.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Bacterial Cellulose Dressing versus Vaseline Gauze in Partial Thickness Burn Wounds and Skin Graft Donor Sites: A Two-Center Randomized Controlled Clinical Study

Pan

Han

Chen

et al. 2022

Evidence-Based Complementary and Alternative Medicine

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Objective. Bacterial cellulose (BC) dressing, which can maintain a moist environment and prevent the invasion of pathogens, has become a competitive dressing material for burn wound treatment. This study was conducted to evaluate the treatment efficacy of a novel China-made BC dressing for the treatment of second-degree burn wounds and skin graft donor sites. Methods. 212 patients with second-degree burn wounds or skin graft donor sites were enrolled from two research centers. They were randomly assigned to the BC dressing group (study group) or the Vaseline gauze (VG) dressing group (control group). Wound conditions were assessed before and after treatment. Dressings were changed according to the condition of the wound bed. Healing rate and healing time were recorded as primary endpoints to evaluate the efficacy of BC dressing against VG dressing. Erythema, swelling, exudation, bleeding, subeschar purulence, and pain were assessed as secondary endpoints. Results. 207 participants completed the trial and their wounds all healed within 28 days. The average healing times for superficial and deep secondary burn wounds and skin graft donor sites in the BC group were 8.12, 15.77, and 10.55 days, respectively. In the VG group, the average healing times for superficial and deep secondary burn wounds and skin graft donor sites were 9.30, 15.27, and 11.19 days, respectively. The healing time of superficial burn wounds in the BC group was statistically shorter than that in the VG group. There was no difference in the frequency of dressing changing between two groups. The BC dressing showed equal efficacy with the VG dressing at all secondary endpoints. Conclusion. The novel BC dressing could be used for the management of second-degree burn wounds and skin graft donor sites. With a shorter healing time in superficial secondary burn wound than that of the VG dressing, the BC dressing showed noninferiority in the treatment of superficial and deep secondary burn wounds and skin graft donor sites versus the VG dressing. This study is registered with the Chinese Clinical Trial Registry (registry number: ChiCTR1800014377 (http://www.chictr.org.cn)).

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“…The Gaxilose test is an innovative, non-invasive diagnostic tool to evaluate lactase activity [66]. This test involves administering gaxilose (galactose β1-4 xylose)=-a synthetic disaccharide akin to lactose, which is similarly processed by intestinal lactase into galactose and xylose.…”

Section: Diagnosismentioning

confidence: 99%

Prebiotic Strategies to Manage Lactose Intolerance Symptoms

Angima,

Qu,

Park

et al. 2024

Nutrients

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Lactose intolerance, which affects about 65–75% of the world’s population, is caused by a genetic post-weaning deficiency of lactase, the enzyme required to digest the milk sugar lactose, called lactase non-persistence. Symptoms of lactose intolerance include abdominal pain, bloating and diarrhea. Genetic variations, namely lactase persistence, allow some individuals to metabolize lactose effectively post-weaning, a trait thought to be an evolutionary adaptation to dairy consumption. Although lactase non-persistence cannot be altered by diet, prebiotic strategies, including the consumption of galactooligosaccharides (GOSs) and possibly low levels of lactose itself, may shift the microbiome and mitigate symptoms of lactose consumption. This review discusses the etiology of lactose intolerance and the efficacy of prebiotic approaches like GOSs and low-dose lactose in symptom management.

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Phase IV noninferiority controlled randomized trial to evaluate the impact on diagnostic thinking and patient management and the test–retest reproducibility of the Gaxilose test for hypolactasia diagnosis

Abstract: Supplemental Digital Content is available in the text

Cited by 6 publications

References 22 publications

Evaluation of Bacterial Cellulose Dressing versus Vaseline Gauze in Partial Thickness Burn Wounds and Skin Graft Donor Sites: A Two-Center Randomized Controlled Clinical Study

Prebiotic Strategies to Manage Lactose Intolerance Symptoms

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