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Research Flourishes on Promise of Fecal Transplants

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Aug. 1, 2018 -- Madelynn Hernandez was in a battle. The California teenager loved to draw, dance, and study math, but her Crohn’s disease was seriously getting in the way.

“I had so much nausea, and my head was often spinning,” she says. “Sometimes I had good days and I was fine, but on the bad days, I just wanted to stay at home and lie on the couch. I was missing a lot of school.”

So last fall, when her doctor talked to her about being part of a study of new treatments for young people with bowel diseases, Hernandez jumped at the chance, even if it meant having someone else’s fecal matter put inside her body.

At the time, Hernandez was taking more than a dozen pills and supplements a day, and never knew if during the school day she would have to run to the bathroom to deal with diarrhea.

“I wanted to help other kids, and I was willing to try anything that would help me feel better,” Hernandez says.

Her doctor, Sonia Michail, MD, a pediatric gastroenterologist and researcher at Children’s Hospital Los Angeles, got Hernandez enrolled in a clinical trial to determine the safety of fecal transplants for Crohn’s patients.

It’s part of a 5-year, 10-person study sponsored by Children’s Hospital LA, in which fecal transplants are used to treat inflammatory bowel diseases like Crohn’s and ulcerative colitis, as well as autism.

Crohn’s disease is a chronic condition that for unknown reasons causes the body’s immune system to attack the intestines.

Changing the Gut to Change the Immune System

Fecal transplants are one of the hottest areas of new medical research, as scientists have come to understand the role the microbiome -- the billions of bacteria that live in and on the body -- plays in health.

Though researchers are still trying to understand how the microbiome works, evidence has been mounting that the makeup of the microbiome affects the body’s immune system.

A fecal transplant is like an organ transplant, in that biological material from a healthy person is given to a sick person to replace something they lost.

Scientists theorize that what has been lost in the sick patient is good bacteria. Stool from a healthy donor, transplanted into a sick person, can change the balance of bacteria in the gut and restore it to health.

Fecal transplants are delivered through colonoscopy, enema, pills, or a tube that is inserted through the nose and travels to the small intestine.

More than 200 studies, almost 20 of which focus on children, are examining whether they can be used to treat diseases. The research involves a range of conditions from inflammatory bowel diseases, like Crohn’s disease, to peanut allergies, according to clinicaltrials.gov, a database of global public and private clinical trials maintained by the National Library of Medicine.

In January 2018, the American Gastroenterological Association, with funding from the National Institutes of Health, enrolled its first patient in one of the largest fecal transplant research efforts to date, called the Fecal Microbiota Transplantation National Registry. The registry enables researchers in various studies to pool their data and to track 4,000 fecal transplant patients over 10 years. The aim is to find out risks and long-term benefits of fecal transplants.

“There is still a lot of unknowns with fecal transplants,” says Stacy Kahn, MD, of the Inflammatory Bowel Disease Center at Boston Children’s Hospital. She leads two studies looking at fecal transplants to treat Crohn’s disease and ulcerative colitis, a condition in which the immune system attacks the colon. Risks of a fecal transplant include infection, diarrhea, stomach discomfort, and flare-ups of symptoms.

“A number of case series have shown promising results, but much more research is needed, especially in children,” Kahn says.

There have been a few randomized, controlled trials of fecal transplants for inflammatory bowel disease, she says. Each of them, however, has been different in some way, making it difficult to compare results.

“Right now we just don’t know what works and what doesn’t,” she says.

There isn’t a cure for Crohn’s disease or ulcerative colitis. About 5% of the more than 1.6 million Americans that are diagnosed with inflammatory bowel disease each year are children, according to the Crohn’s and Colitis Foundation.

The cause is also unknown, though some data point to genes playing a role. Researchers theorize that patients’ genetic makeup can lead to a reduction in certain bacteria that help the gut work smoothly.

The standard treatment involves a lifetime of taking multiple drugs aimed at reducing intestinal inflammation. Many of the drugs have serious side effects, like fatigue, nausea, and vomiting, driving many to seek alternative treatments like fecal transplants.

Special Push to Help Children

Children in the U.S. cannot get a fecal transplant except through a clinical trial. The FDA permits fecal transplants as an “investigational new drug” that can be used to treat people with severe and recurring infections caused by Clostridium difficile (C. diff), if standard treatments have failed. A group of lawyers, researchers, doctors, patient advocates, and fecal transplant banks are working to change the FDA rules to make it easier for patients to access fecal transplants for not only C. diff, but to treat other diseases.

C. diff can cause symptoms from severe diarrhea to life-threatening inflammation of the colon. It can thrive when antibiotics have killed off other healthy bacteria in the gut. About 500,000 Americans, including children, get sick from C. diff each year, and as many as 29,000 people die from it, according to 2011 statistics from the CDC.

Over the past decade, dozens of studies have shown that a fecal transplant has cured about 90% of adult C. diff patients. The overall cure rate for children with repeated C. diff infections was 87% with a fecal transplant, according to preliminary results of a study Kahn co-wrote. The data are decisive enough that the Infectious Diseases Society of America in February 2018 updated its guidelines and recommended that doctors consider using the procedure for people with C. diff who have not been cured by standard treatments, such as antibiotics.

The C. diff data have encouraged doctors like Michail to look into whether the benefits extend to other diseases. Michail is leading the three clinical trials at Children’s Hospital LA.

“So far, fecal transplant seems to be the most effective way to appropriately change the microbiome for health,” she says.

Since receiving her fecal transplant, Hernandez’s Crohn’s disease remains in remission, and she has stopped taking most of her medications. In the next few months, the now 16-year-old expects to eliminate all of them.

“I feel so much better,” Hernandez says. “No stomach pain, no diarrhea.”

WebMD Article Reviewed by Arefa Cassoobhoy, MD, MPH on August 01, 2018

Sources

Madelynn Hernandez.

Tania Hernandez.

ClinicalTrials.gov.

News release, American Gastroenterological Society.

Sonia Michail, MD, pediatric gastroenterologist and researcher, Children’s Hospital Los Angeles.

Stacy Kahn, MD, Inflammatory Bowel Disease Center, Boston Children’s Hospital.

InflammatoryBowelDisease.net: "Statistics."

University of Minnesota Center for Infectious Disease Research and Policy: "Experts call for new approach to regulating fecal transplants."

CDC: "Clostridium difficile Infection."

Cochrane Library: "Fecal transplantation for treatment of inflammatory bowel disease."

Annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, Las Vegas, Nov. 1-4, 2017.

Clinical Infectious Diseases: "Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA)."

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