From The Editor | January 12, 2016

Can You Guess What This Trial Is Using To Fight Obesity?

Source: Clinical Leader
Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

Can You Guess What This Trial Is Using To Fight Obesity?

There is a lot of excitement in the clinical space right now, with new technologies bringing needed efficiencies, the focus on patient centricity, and Robert Califf possibly set to become the newest head of the FDA. With all of that going on, it can be easy to overlook some of the not-as-noteworthy events happening in the space. I’m talking, of course, about the soon-to-be launched trial that will help individuals to lose weight…by eating poop.

I wish I could say I’m kidding, but I’m not. An article by John Samuels on CDA News notes a promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans. The fecal matter will be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.

In case you’re wondering, the trial will begin in late January and is listed on ClinicalTrials.gov. The pills will be administered to trial participants once a week for six weeks, with their health and weight recorded at three, six, and 12 months on a metabolic scale. The pills will be double encapsulated and are both tasteless and odorless. They reportedly will not release until reaching the right location in the large intestine.

Multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism. In this study, subjects will receive FMT capsules from lean metabolically healthy donors to study effects on body weight and insulin sensitivity. Subjects who participate will be randomized 2:1 to receive either active FMT capsules or placebo capsules. Subjects and providers will be blinded to treatment assignment.

The hope is to get microbes in the digestive tracts of obese individuals to become more like those in thin, healthier individuals, eventually causing them to shed pounds. The research team overseeing the study is not sure what the outcome will be, but admit they are cautiously optimistic.

In 2013 a study conducted on mice found those that consumed microbes from thin humans tended to stay thin. Those that received microbes from an obese individual grew fat. The microbes were taken from human twins where one individual was thin and the other obese. The research was fueled by a growing fascination with gut bacteria and the role it can play in diseases such as Crohn’s and irritable bowel syndrome. Two researchers who reviewed the results called them “A powerful set of experiments” and “the clearest evidence to date that gut bacteria can help cause obesity.” The new trial will take the research a step further and hope to address other unanswered questions.

If researchers are able to identify which bacteria are responsible for the weight effect, eventually humans will be able to take pure mixtures of bacteria rather than feces.

Of course bacteria are not the only determinant of weight. Diet, exercise, and genetics play a role as well. Gut bacteria also varies from one individual to the next. But researchers remain optimistic about the outcome of the trial.

According to the study information on ClinicalTrials.gov, the primary outcome measure is body weight, but secondary measures include change in insulin sensitivity and changes in lean and fat mass measured via dual-energy x-ray absorptiometry.

Adults of both sexes between the ages of 25 and 60 years are eligible for the study. According to the website, healthy volunteers need not apply. Unless you’re looking to donate.