The Role Probiotics Can Play in Gut Health

Atlantia Clinical Trials first conducted a pilot study to assess the carry-over effect and establish the necessary washout period for the randomized, double-blind, placebo-controlled crossover study and provide preliminary data on subject characteristics and the variation of the measured parameters.

Irritable Bowel Syndrome (IBS) typically relates to chronic abdominal pain, bloating, discomfort and altered bowel habits and affects 10-15% of the general population.

In a recent study, Atlantia used two well-characterized probiotic strains, each with interesting IBS-related properties. The former has demonstrated its ability to alleviate anxiety and stress and improve cognition in preclinical and clinical studies.

The second strain has already been extensively researched and shown to regulate inflammatory responses and minimize abdominal pain, bloating, gas, and unpredictable bowel habits in IBS subjects in two well-managed clinical studies.

Therefore, the aim of a recent trial was to assess the effect of a mixture of the two strains on gut symptoms and stress/mood in adults with IBS. The research project consisted of two phases: a pilot study and a randomized, double-blind, placebo-controlled crossover study.

Challenges and goals

The primary objective was to evaluate the study product and its influence on stress and mood in adults with IBS based on change in HAD score.

Other objectives included evaluating the effect of the product on IBS symptoms, abdominal pain/discomfort, and individual symptoms, such as abdominal bloating/distention, abdominal pain/discomfort, Urgency of stools, frequency of stools, consistency of stools (Bristol scale), straining and passage of gas.

During the study, the safety of the investigational product was assessed on the basis of serious and non-serious adverse events and safety parameters. The biggest challenge was to verify that an interruption of one period did not have a residual effect that carried over to the next period in a crossover design.

This is called a carryover effect. Therefore, a technical team familiar with these designs was needed.

How Atlanta’s Solution Helped

Atlantia’s team of physicians, scientists, nutritionists, and research nurses collaborated with sponsor researchers to design and achieve key study objectives.

The in-house team of stress and anxiety experts was a perfect match for the sponsor’s research requirements, and the Atlantia team of experts recommended a crossover study design.

Each participant acted as their control, and both interventions (the investigational product and the placebo) were evaluated for the same individual. This facilitated a trial with precision comparable to that of a parallel group trial using only half the sample size.

Image Credit: Atlantia Clinical Trials

About the study

The underlying factors contributing to IBS are heterogeneous and not fully understood, but alterations in gut mucosal immune activation cognitive function, increased psychological stress, brain-gut interaction and changes in the gut microbiota all contribute significantly to disease.

Atlantia initially conducted a pilot study to assess the carry-over effect and establish the required washout period for the randomized, double-blind, placebo-controlled crossover study and provide preliminary data on subject characteristics and parameter variation. measures.

In the pilot study and the crossover study, stress and mood were measured using approved questionnaires and other biological biomarkers.

Bowel symptoms were assessed using self-report methods that considered abdominal pain, passing gas, stool form and consistency, and stool effort and urgency. daily using a Electronic journal system. Other measures include a weekly global assessment of IBS symptoms and abdominal pain/discomfort.

The Role Probiotics Can Play in Gut Health

Image Credit: Atlantia Clinical Trials

Atlantia recruited subjects through its database, GP practices, and advertisements in local newspapers.

Subjects were first screened by telephone, answering questions regarding their age, mood and stress history, gastrointestinal symptoms, and past and current medications. Subjects deemed eligible were then scheduled for a face-to-face screening visit.

The study was conducted as detailed in the protocol and in accordance with ICH guidelines on good clinical practice and the Declaration of Helsinki.

The pilot study was an open design as detailed below.

The volunteers all took the experimental product for 8 weeks, followed by an 8-week control.

The volunteers were pre-selected according to the selection criteria. Subjects were screened to identify and select from a group of participants aged 18-55 with repeated abdominal pain/discomfort and mild to moderate stress/mood.

The study required visits over a period of 20 weeks: at each visit, a blood sample was taken. A urine sample was collected at screening and referral visits, and at the end of the procedure. For women of childbearing age, a pregnancy test was performed.

Each morning of a visit, subjects were advised to avoid brushing their teeth or using mouthwash as a saliva sample was taken the morning of each visit. Subjects received a stool collection kit at the visits and were asked to collect a sample at home and bring it to the clinic for each subsequent visit.

Stool samples were stored at -80 ºC and analyzed for the presence/absence of probiotic strains as an indication of probiotic strain transit/washout and retained for compositional analysis, microbiota diversity analysis , SCFA analysis and metabolomics.

The second study was a randomized, double-blind, placebo-controlled study using a repeated measures crossover design as described.

The volunteers were pre-selected according to the selection criteria. Participants ranged in age from 18 to 55 years old and suffered from IBS with recurrent abdominal pain/discomfort and mild to moderate stress/mood.

The study required periodic visits for 28 weeks. Volunteers were randomized to Group 1 or Group 2. They then underwent an 8-week intervention with either the investigational product or a matching placebo with a washout period between interventions.

In addition, urine, saliva, blood, and fecal samples were collected during the crossover study to assess parameters similar to those of the pilot study.

About Atlantia Clinical Trials

Atlantica Clinical Trials Ltd. is a CRO specializing in conducting food, beverage and supplement studies for companies around the world who wish 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-renowned scientists (in the top 1% internationally, in the areas of digestive health and functional foods) at: the APC Microbiome Institute at University College Cork, Ireland; Teagasc, Moorepark, Ireland and globally recognized centers of excellence.

Atlantia manages and operates its own clinical sites and conducts all studies in accordance with the ICH-GCP (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice) standard. Its team includes physicians who are experts in digestive health, mental health (psychological stress and cognition), cardiovascular health, sports performance, metabolic diseases, bone health, immune health and healthy aging. The clinical team also includes project managers, research nurses, nutritionists, certified athletic trainers and laboratory researchers.

Atlantia manages all elements from protocol design, placebo manufacturing, study recruitment and execution, to sample and data analysis, statistics and report/record preparation for to provide technically, scientifically and clinically superior service.

Clinical studies cover a wide range of functional food and beverage categories, such as dairy, cereals, probiotics, different forms of protein, infant-specific foods, vitamins/minerals, plant or marine extracts and medical foods.

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