Daniel M. Keller, PhD

June 22, 2016

BERLIN — Consuming a special formulation of fermented milk containing multiple probiotics and prebiotic fiber relieved constipation to a greater degree than placebo for patients with Parkinson's disease (PD), a study finds.

"We were able to demonstrate that treatment for 4 weeks with fermented milk containing multiple probiotic strains and prebiotic [fiber] can really improve constipation in Parkinson's disease," said lead author Emanuele Cereda, MD, PhD, from the Policlinico San Matteo in Pavia, Italy.

"We obtained positive results for the primary and for all the secondary endpoints we addressed with this trial."

Dr Cereda presented the results here at the 20th International Congress of Parkinson's Disease and Movement Disorders.

Constipation affects about 60% of patients with PD and is the most common dysautonomic nonmotor symptom for these patients.

A prebiotic is a specialized plant fiber that induces growth or activity of the endogenous beneficial bacteria already present in the gut.

In a double-blind trial, Dr Cereda and colleagues randomly assigned 120 patients either to 125 mL of fermented milk containing multiple probiotic bacterial strains and prebiotic fiber (n = 80) or to placebo (n = 40) once daily for 2 weeks.

"I think this is one of the largest trials you can find for these patients using a nonpharmacologic treatment for the improvement of this complication," he told Medscape Medical News.

Patients were confirmed to have constipation according to Rome III criteria after completing a 2-week baseline stool diary. They were encouraged to stay well hydrated, and laxatives were allowed during the trial, making the experimental regimen an adjunctive treatment, rather than a replacement.

Good Efficacy, Tolerability

More patients in the experimental group achieved the primary efficacy endpoint of an increased number of complete bowel movements (CBMs) per week compared with the placebo group.

At baseline, both the treatment and placebo groups had a mean of 2.2 CBMs per week. At week 4 of treatment, the group consuming the fermented milk product had a mean 3.4 CBMs (mean increase of 1.2/week; 95% confidence interval, 0.8 - 1.6) vs an increase of only 0.1/week for the control patients (P = .002).

A key secondary endpoint was the proportion of patients achieving increases in the number of CBMs per week. A greater proportion of patients consuming the fermented milk product had increases in the number of CBMs, as well as other measures indicating efficacy with the product.

Table. Efficacy of Fermented Milk Product

Endpoint Experimental Group (n = 80) Placebo Group (n = 40) P Value
Three or more CBMs in week 3 - 4 (%) 58.8 37.5 .03
Mean increase in stool consistency* 0.7 0.1 .018
Mean decrease in use of laxatives, week 3 - 4 0.8 0.1 .018
Satisfied/very satisfied (%) 55.0 17.5 <.001
Likely to continue treatment (%) 56.3 30.0 .008

*Stool consistency, Bristol Stool Form Scale score.

There were no adverse effects, except one patient in each group discontinued the trial for mild abdominal discomfort.

Because the use of laxatives was allowed, Dr Cereda said he was not able to assess the standard measure of the number of complete spontaneous bowel movements, but only the number of CBMs, although patients were asked to reduce the use of laxatives as much as possible.

Per Odin, MD, PhD, from the Klinikum Bremerhaven, Germany, who led a poster tour including this study, commented to Medscape Medical News that the fermented milk product appeared to be almost without adverse effects and risks, "so if it really works as well as they indicate, it could very well have a future. I think that they should continue to explore it."

More controlled studies would be needed to be able to separate the efficacy of the product from hydration and fiber ingestion. And Dr Odin said comparative studies with existing treatments would be of interest, as would any changes in stool microbiology before and after using the product to possibly explain its effects and elucidate mechanisms.

"But I think that the main thing for deciding if it will have a chance on the market will be the degree of effect [vs] existing treatments and the safety side, of course," he said.

The fermented product was a special formulation with a high level of probiotics not available on the market, and Dr Cereda said it was "a little bit expensive." He said he hopes that with the cooperation of industry, they will be able to design another, more affordable product.

Dr Cereda and Dr Odin have disclosed no relevant financial relationships.

20th International Congress of Parkinson's Disease and Movement Disorders: Abstract 299. Presented June 20, 2016.

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