This article will give an example of a study demonstrating how a GCP standard trial design can deliver successful results for a Sponsor when researching variable and subjective health conditions in mild symptoms of the self-diagnostic populations or in healthy populations.
About the Sponsor
It was the intention of a well-established multinational company to gain a deeper understanding of their food ingredient and if it could reduce gastrointestinal symptoms and digestive discomfort in adults who have not been diagnosed with gastrointestinal disorders.
Challenges and objectives
There are no agreed biomarkers of digestive discomfort, and it is very subjective as it can vary from individual to individual, making clinical studies of gastrointestinal health difficult. This means that in order to succeed, good clinical design is paramount.
The objective was to determine if the investigational product (a dietary supplement/functional food ingredient) after six weeks of ingestion could relieve mild digestive disorders, including stomach discomfort, flatulence, and abdominal bloating in healthy subjects.
How Atlantia’s solution helped
APC Microbiome Ireland has well-established clinical experience with gastrointestinal health, making them an obvious choice to partner for such a study with Atlantia.
After consulting with the Sponsor, Atlantia designed and delivered a clinical study to ascertain if the investigational product could alleviate digestive symptoms in healthy subjects, including stomach discomfort, flatulence, and abdominal bloating. The study objectives were delivered by Atlantia both on budget and on time.
About the study
Ethics Board approval was granted after the study was designed by the clinical studies team (scientists, nurse manager, human studies coordinator and gastroenterologist) in consultation with the Sponsor.
Image Credit: Atlantia Clinical Trials
The study was carried out to GCP standards and was a placebo-controlled, double blind, parallel study.
Sixty healthy female subjects with mild gastrointestinal symptoms were recruited. A combination of inflammatory markers was measured, along with self-reported symptoms via a daily symptom diary. Once an initial phone screen with a nurse was completed, the clinical study involved 4 study visits over a period of 10 weeks:
The first visit was a screening visit. It was held for interested subjects and included an in-detail explanation of the study. If they wished to participate, subjects signed a consent form, and medical information was taken. Subjects were screened for symptoms of IBD and IBS, and they were excluded if positive.
Following the screening visit, a baseline visit was conducted in week 1. Subjects identified as suitable were randomly assigned into one of three treatment groups (placebo and 2 different doses of test product), and each received a six-week supply of the study product.
Subjects were given instructions for completing a daily symptom diary (self-reporting questionnaire) to assess any changes in flatulence, bloating and stomach discomfort. The volunteers were contacted by the research nurse a number of times throughout the 6 weeks to ensure compliance.
At week 6, all subjects returned for a study visit. All product packaging was returned, both full and empty, to assess subject compliance.
The final visit occurred in week eight, two weeks after ingestion of the test product was completed, to establish if the expected effect of the doses was still occurring.
Blood samples were collected and then analyzed for cytokines and inflammatory markers at each time point. There was a statistically significant reduction in GI discomfort following an analysis of the results in the Clinical Study Report provided by Atlantia.
About Atlantia Clinical Trials
Atlantia Clinical Trials Ltd is a CRO that specializes in conducting studies in foods, beverages and supplements for companies world-wide that want to scientifically validate their functional ingredients to support an: EFSA (European Food Safety Authority) Health Claim; FDA (Food & Drug Administration) Structure Function Claim; or General Product Marketing Claim.
Atlantia works with world leading scientists (among the top cited 1% internationally, in the areas of digestive health and functional foods) at the: APC Microbiome Institute in University College Cork, Ireland; Teagasc, Moorepark, Ireland and recognized centers of excellence globally.
Atlantia runs and operates its own clinic sites and conducts all studies to ICH-GCP standard (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice). Its team includes physician experts in digestive health, mental health (psychological stress and cognition), cardiovascular health, sports performance, metabolic disease, bone health, immune health and healthy ageing. The clinical team also includes project managers, research nurses, nutritionists, certified sports trainers and lab researchers.
Atlantia manages all elements from protocol design, placebo manufacture, recruitment, and study execution, to sample and data analysis, statistics and report/dossier preparation to provide a service which is technically, scientifically and clinically superior.
The clinical studies cover a broad spectrum of functional food and beverage categories, such as dairy, cereal, probiotic, different protein forms, infant-specific foods, vitamins/minerals, plant or marine extracts and medical foods.
Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.