Publication

Effects of a Synbiotic in Constipation

A randomised, double-blind, placebo-controlled clinical study: the effects of a synbiotic, Lepicol, in adults with chronic, functional constipation

Get in touchRead more

Publication Overview

The study objective was to evaluate the safety and effects of Lepicol (psyllium fibre, inulin and 5 probiotic strains) in adults with chronic, functional constipation during a 4 week intervention. 69 subjects with functional constipation according to Rome III criteria were randomised to receive Lepicol (n ¼ 35) or placebo (n ¼ 34) daily. Both groups had improved frequency of bowel movements, with an increase of 1.082 bowel movements in the Lepicol group over placebo after one week, and 1.079 more than placebo after week 2, but with no significant difference at week 4.Both groups showed significant improvements in quality of life scores at 4 weeks, with the average score being 12.033% better in the Lepicol group, which also had 15.2% improvement in intensity of symptoms and 28.5% increase in satisfaction with quality of life compared to the placebo. Symptoms of constipation improved to a greater degree and there was a significant reduction in laxative use in the Lepicol group.

Publication Results

While this study did not reach its primary endpoint of increasing bowel movements per week (due to the low subject numbers and high placebo effect), it did demonstrate that a twice daily consumption of the synbiotic, Lepicol, improved the quality of life of subjects with constipation. Lepicol did increase bowel movements per week significantly in the first 2 weeks in subjects with chronic, functional constipation but the significance was not maintained over placebo in weeks3 and 4. Lepicol also improved the overall quality of life scores (PAC-QOL) and constipation symptoms(PAC-SYM) at 4 weeks, and reduced the use of laxatives during the study versus placebo. In addition, Lepicol was safe. Therefore, this food supplement, containing fibre, prebiotic and five probiotic strains, has the potential to offer relief from symptoms of functional constipation.

Sponsor & Volunteer Testimonials

“Extremely impressed on delivery of project... ”

“Updates were relevant and timely, I never felt that I wasnt informed properly. Extremely impressed on delivery of project during the COVID-19 pandemic. Clearly a lot of effort and work has been put in to making sure operations have been running as close to perfect as possible.”

- Nutrition Scientist at the largest producer of dairy products in Scandinavia

“very flexible and responsive, very transparent..."

"High quality work, expertise in nutritional intervention studies, very flexible and responsive, very transparent. Atlantia has a personal touch which makes working with you a lot of fun. It was assuring and great to see that the leadership are very knowledgeable and still very much involved in details of the work".

- Nutrition Manager at a global leader in collagen-based solutions

“Adaptability with trial design and inputs is great!"

"Adaptability with trial design and inputs is great! I expect them to be able to answer the questions I have and they always do."

‍

- Head of Clinical and Regulatory Affairs at revolutionary company tackling diabetes, heart disease, and obesity

“I trust Atlantia in their capabilities...”

"I was satisfied of the service provided and I trust Atlantia in their capabilities to conduct successfully clinical trials. We have good previous experience together and I know Atlantia is always improving".
‍

- Nutrition Research Manager at multinational functional ingredients company tackling bone health

“...expertise, way of working and customer friendliness... ”

"We expected (and got) solution-orientated answers in a suitable time frame, we appreciated the overall service of Atlantia (including the expertise, way of working and customer friendliness)"

‍

- Nutrition Scientist at multinational functional ingredients company tackling body composition

“This disease would of taken another few years to diagnose...”

"Really great people to deal with!!! I have done a few trials and have found them exceptional at what they do. I completed a pill camera trial about 2 years ago. From doing so it was found I had Crohn's disease. This disease would of taken another few years to diagnose had I not done this trial."

- Volunteer who help us and took part in our Video Camera Endoscopy trial

“...very professional and friendly..."

"All the staff I have met have been very professional and friendly and the trials have been interesting, educational and ultimately beneficial to my health".

-Participant member of our volunteer database for trials

“...everything was explained perfectly”

"Very friendly staff and everything was explained perfectly, also they had to take bloods and I'm the biggest baby when it comes to needles, but I didn't even realise they were finished, they were that good."

-Volunteer who took part in our food bioavailability studies

“... treated me with respect ...”

"I thought that that the staff at Atlantia always treated me with the utmost respect and my health was always at the forefront."

-Member of our participant database who took part in multiple studies





Media & Resources