I don’t know about you but when I learned about Fecal Microbial Transplantation (FMT) I brushed the initial grossness aside and got really excited about it. It’s simple, cheap and harbors no significant or serious side effects or long term problems. For folks with very serious conditions like Crohn’s and ulcerative colitis, this may turn out to be a ticket back to health.
First Trial Using FMT in Children Gets Great Results
The Helen DeVos Children’s Hospital is the first in the country to complete a phase 1 clinical trial using fecal transplantation. Their results were published in the Journal of Pediatric Gastroenterology and Nutrition in 2013. They found that the treatment with FMT resulted in the improvement or elimination of symptoms in most pediatric patients with active ulcerative colitis.
FMT is a process that involves infusion of human stool from a healthy donor into the intestine of the patient in order to restore healthy microbial flora in the intestines of the patient.
This is turning out to be a powerful method of administering the ultimate probiotic that may far exceed results from oral administration of probiotics of only a few strain. Human stool contains hundreds of strains — many of which are yet unidentified — that are symbiotic with us.
Poop is Now Drug
Because this is being used to treat a disease, human stool in this capacity is classified as a biologic and a drug. The hospital had to get approval from the FDA to conduct this trial for the treatment of ulcerative colitis.
FMT has been used for the treatment of C. difficile infections with great results and now researchers are expanding the use of this therapy for ulcerative colitis. This is great news!
According to Sachin Kunde, MD, MPH, pediatric gastroenterologist, Spectrum Health Medical Group, and lead investigator,
We believe that the procedure may restore ‘abnormal’ bacteria to ‘normal’ in patients with ulcerative colitis. Our short-term study looked at the safety and tolerability of FMT for these patients… Our study showed that fecal enemas were feasible and well-tolerated by children with ulcerative colitis. Adverse events were mild to moderate, acceptable, self-limited, and manageable by patients.
He goes on to say,
We must further investigate standardization of FMT preparation, ideal donor selection, the best route of administration, and optimal duration or scheduling of FMT to induce and maintain a clinical response.
This single-center pilot study enrolled 10 children and young adults, ages 7-20 years, with mild to moderate ulcerative colitis. Lab-prepared stool samples from a healthy adult donor were infused via enema daily for five total infusions, scheduled within one week.
Results of the Trial
They found that 78% of the subjects achieved clinical response within one week while 67% maintained clinical response at one month after FMT. Thirty-three percent subjects did not show any symptoms of ulcerative colitis after FMT.
They also found that the patient’s clinical disease activity (PUCAI score) significantly improved after FMT compared to the baseline. There were no serious adverse events. One of the 10 subjects could not hold the enema — it is a retension enema.
What is Ulcerative Colitis?
Ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine, or colon, and rectum. Symptoms can present slowly or occur suddenly and include abdominal pain, cramping, bloody diarrhea, pus in the stool, fever, rectal pain, weight loss, nausea, vomiting, joint pain, mouth sores, skin lesions and slow growth in children.
It can be debilitating with hospitalizations and strong medications, including steroids and biologics that have many serious side effects and significant long term effects. Most of the medications for this condition used for children have not been studied in children.
The Crohn’s and Colitis Foundation reports that as many as 700,000 Americans are affected by ulcerative colitis, and approximately 25 percent are diagnosed during childhood.
Standard of Care for IBD Does Not Include Diet
Interestingly, there are still plenty of gastroenterologists that say that diet does not affect Crohn’s or ulcerative colitis. However, many patients are starting to hear about special diets like Specific Carbohydrate Diet and the GAPS diet. These diets address the inflammation that is in the intestines.
Even with a change of diet many people suffering from IBD still need some sort of treatment. If the dietary changes can decrease the need for medications by 50% that is great — but the medications still have side effects that are worrisome.
Conventional Medications for IBD
- The first level of treatment includes the Aminosalicylates (5-ASA). These include medications that contain 5-aminosalicylate acid (5-ASA). They work at the level of the lining of the GI tract to decrease inflammation.They are thought to be effective in treating mild-to-moderate episodes of ulcerative colitis and useful as a maintenance treatment in preventing relapses of the disease. They work best in the colon. Rare side effects include headache, kidney problems and pancreas problems (pancreatitis).
- Corticosteroids are given next if the disease is not controlled by the ASA drugs. Prednisone and methylprednisolone are available orally and rectally. Corticosteroids nonspecifically suppress the immune system and are used to treat moderate to severely active ulcerative colitis. These drugs have significant short- and long-term side effects and should not be used as a maintenance medication. Side effects include weight gain, excessive facial hair, mood swings, high blood pressure, type 2 diabetes, osteoporosis, bone fractures, cataracts, glaucoma and an increased susceptibility to infections.
- Immunomodulators are next. This class of medications modulates or suppresses the body’s immune system response so it cannot cause ongoing inflammation. Immunomodulators generally are used in people for whom aminosalicylates and corticosteroids haven’t been effective or have been only partially effective. They may be useful in reducing or eliminating the need for corticosteroids. They also may be effective in maintaining remission in people who haven’t responded to other medications given for this purpose. Immunomodulators may take several months to begin working. Side effects can include allergic reactions, bone marrow suppression, infections, and inflammation of the liver and pancreas. There also is a small risk of development of cancer with these medications.
- Antibiotics are used when infections—such as abscesses—occur. They can also be helpful with fistulas. Antibiotics used to treat bacterial infection in the GI tract include metronidazole, ampicillin, ciprofloxacin, others. We all know about the potential side effects of antibiotics.
- Biologic Therapies are a last resort and are also known as anti-TNF agents. They are used for people suffering from moderate-to-severe ulcerative colitis. Tumor necrosis factor (TNF) is a chemical produced by our bodies to cause inflammation. Antibodies are proteins produced to attach to these chemicals and allow the body to destroy the chemical and reduce the inflammation — these drugs find TNF in the bloodstream and removes it before it causes inflammation in the intestinal tract. These drugs have been linked to an increased risk of infection, especially tuberculosis and reactivation of viral hepatitis, and may increase the risk of blood problems and cancer. They can also cause severe allergic reactions in some people.
Low Tech Low Cost Treatment Versus Standard Protocol With Dangerous Side Effects
It is so encouraging that a hospital group is pursuing what can become a low tech, low cost treatment that patients can practically do at home. Hopefully Big Pharma won’t jump on this and turn it into a patented, unnecessarily expensive procedure.
Would you do this treatment if you had a serious condition like ulcerative colitis or Crohn’s disease and had to take dangerous medications? Leave a comment and let me know!