The Gastrointestinal Symptoms Evaluation for Nutritional Supplements (GSENS): Preliminary development and validation

Abstract

Background: Long-chain omega-3 polyunsaturated fatty acid (LCn-3PUFA) supplements are becoming increasingly used in clinical trials. Gastrointestinal disturbances are commonly reported following the consumption of these supplements, which may lead to poor compliance. There are currently no gastrointestinal symptom rating scales designed to specifically measure the frequency and severity of these symptoms. Objective: To examine the frequency and severity of gastrointestinal symptoms in children and adolescents. Design: Eighteen children and adolescents aged 8-18 yrs rated their mood, behaviour and the frequency and severity of 11 gastrointestinal symptoms commonly reported in clinical trials of nutritional supplements over the previous week. Gastrointestinal symptoms were grouped according to severity. Outcomes: Principal Components Analysis indicated that gastrointestinal symptoms could be grouped according to three levels of severity: minor (reflux, bloating, cramping, flatulence and constipation), sub-acute (urgency to pass stool, nausea and loose stool) and acute (pain, diarrhoea and vomiting). Participant scores on the GSENS were positively related to anxiety (r = 0.49, p = 0.040) and depression (r = 0.75, p < 0.001) and negatively related to quality of life (r = -0.53, p = 0.024). Conclusions: The frequency and severity of gastrointestinal symptoms were successfully recorded using the GSENS. Future trials need to monitor gastrointestinal symptoms in larger numbers of participants prior to and following the consumption of LCn-3PUFA supplements. Monitoring of gastrointestinal symptoms may lead to more accurate assessment of the long-term benefits of nutritional supplements, including LCn-3PUFA.