B.C. naturopath's pricey fecal transplants for autism are experimental and risky, scientists say

A Vancouver naturopath who charges $15,000 US for children with autism to have fecal transplants at a clinic near Tijuana, Mexicocould put them at serious risk of infection with an unproven treatment, according to doctors and scientists.

Jason Klop claims in Facebook videos that he's treated kids as young as two from across the world using pills and liquids made from the stool of two American adolescents. He says he's seen "dramatic improvements" in symptoms of autism spectrum disorder.

The processisn't approved ineither Canada or the United Statesfor treatment of autism. Health Canada says it's looking into Klop's operation, and B.C.'s top public health official says she has serious concerns.

Experts on autism and the gastrointestinal system describe the therapy as experimental, overly expensive and potentially unsafe, with little solid basis in research.

"The potential risk of this procedure is way more than any potential benefit, and charging $15,000 to people without having confirmed data really borders on ... being very unethical," said Dr. Kent Williams, a pediatric gastroenterologistat Ohio's Nationwide Children's Hospital who specializes in treating GI issues in children with autismspectrum disorder.

Fecal microbiota treatments, or FMT for short, take bacteria and other microbes from the poop of a healthy person and transfer them to a patient either anally or orally, with the goal of restoring a normal environment inside the gut.

A single exploratory study has suggested that FMT could help improve symptoms of autism spectrum disorder, but even the researchers behind that work say the risks and potential benefits remain unproven.

"If it was my child, I wouldn't do it," said Rosa Krajmalnik-Brown, a professor ofcivil and environmental engineering at Arizona State University, who is part of the team that conductedthe 2019 study.

That's the same advice she gave to a parent who asked for her thoughts on Klop's business though she's also careful to point out that she's not qualified to give medical advice.

Krajmalnik-Brown said she's had hundreds of emails from parents who want to try FMT with their children with autism, and she tells them much more research is needed before it will be an approved therapy.

That's because if something goes wrong in the FMT process, the consequences can be lethal.

Krajmalnik-Brown said both donors and recipients need to be thoroughly screened,and "if this is not done correctly, this can lead to serious infections."

Last year, a 73-year-old man with a compromised immune system died after receiving a transplant from a stool sample contaminated with antibiotic-resistant E. coli.

Naturopaths' college is 'monitoring the situation'

Right now, FMTis only approved for use outside of clinical trials for the treatment of a single condition C. difficile infection that hasn't responded to other therapies.

B.C.'s provincial health officer, Dr. Bonnie Henry, said she would caution all parents against trying FMT for autism, calling it an "experimental, unproven treatment that has dangers."

A spokesperson for Health Canada said the federal government doesn't have any power over treatments provided in other countries, but officials are looking into Klop's operation to make sure he's following the law here in Canada.

The College of Naturopathic Physicians of B.C., on the other hand, does have jurisdiction over B.C. naturopaths, even when they're providing treatment somewhere else.

When asked whether the college has concerns about Klop's business, registrar Phillipa Stanawayat first told CBC she couldn't comment on an ongoing investigation. Asked to clarify, she appeared to backpedal and said she could not confirm that an investigation is underway.

"We are monitoring the situation and will provide further information as we can," she wrote in an email.

'I just want to see dramatic improvements'

Klop initially agreed to an interview with CBC to talk about his business, FMT Solution, but he cancelled a day later. He did not respond to a detailed set of questions sent by email.

Klop tells his followers in his most recent Facebook video that he and his family are now living full time in Mexico.

According to his website, Klop's clients fly to San Diego, Calif.,before they are driven across the Mexican border for five-day "retreats" in the resort city of Rosarito, about a 30-minute drive south of Tijuana. Klop says he accepts 10 children per retreat.

CBC has reached out to six parents who have made posts in private Facebook groups that suggest their children have participated in Klop's retreats. None agreed to an interview.

In a Facebook video posted to one of those private groups on Jan. 3, Klop breaks down the $15,000 US price tag for his retreats.

He said it includes resort accommodations, transportation across the border and a consultation with a Mexican doctor, but the bulk of the cost $12,500 US is for the FMT, which is administered daily for 16 weeks.

Klop has focused exclusively on using FMT to treat autism for the last six months, and his patients come from across North America, Europe, the U.K. and the Middle East, according to the same video.

He says he doesn't like to describe his work as "curing" autism.

"I just want to see dramatic improvements in digestion, language, behaviour, sleep, cognitive abilities, social awareness, social interactions. We see all of those things," Klop said in the video.

"If a child has autism, I think they have the likelihood of benefiting from FMT."

Dr. Christine Lee, a medical microbiologist and infectious diseases physician who studies FMT therapies at Island Health in Victoria, said there isn't solid science suggesting it's effective at treating autism.

She described Klop's price tag as "exorbitant" for this type of therapy, estimating that daily FMT doses cost less than $5 a day, even when the cost of screening donors is taken into account.

"I don't want to sound very negative and judgmental, but if we are subjecting individuals to experimental research, they should not be charged," Lee said.

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In his videos, Klop also claims to have used FMT to treat a variety of other conditions, including multiple sclerosis and Parkinson's disease.

Klop's website posits that "the foundation for all health lies in the gut." In another video, he suggests that the increase in autism diagnoses in recent decades is "primarily due to a degeneration of these children's microbiomes" referring to all the bacteria, viruses and other microbes that live in the human gastrointestinal system.

It's true that gastrointestinal issues are very common in children with autism, said Williams, the Ohio pediatric gastroenterologist,but he believes Klop has the cause and effect mixed up.

"I think the problems from the central nervous system that go along with autism, that's what's causing the GI problems," Williams said.

'Maybe we got lucky'

The last few years have seen a lot of excitement about the potential applications of FMT, and extensive research is currently underway about the possibilities for treating a range of conditions.

Klop's website says he bases his work on the Arizona State University study published last year.

That research followed 18 children on the autism spectrum who also have gastrointestinal problems. The scientistsfound a nearly 50 per cent improvement in autism-related symptoms two years after the subjects received daily FMT therapy for eight weeks.

But as the researchershave been careful to point out, the study was not randomized, did not control for the placebo effect, did notinclude a control group and involved a very small sample size.

Krajmalnik-Brown described the results as encouraging, but said the right thing to do now isconduct a rigorous clinical trial.

"Our results were very promising, but it was only 18 kids. Maybe we got lucky," she told CBC.

Williams said it's crucial to be cautious with the results of a so-called open-label study, in which both the researcher and the patient know who's receiving the therapy.

"The history of open label trials, particularly in autistic children, is very fraught. Initially, the studies are great and promising, but later on they're not as good as initially thought, and in some cases there actually have been severe consequences even death," he said.

Fears children are treated as 'test subjects for their parents'

CBC was first alerted to Klop's operation by Melissa Eaton, a North Carolina mother of a child with autismwho tracks potentially dangerous and unproven treatments for autism by infiltrating private Facebook groups.

She said she was shocked when she learned Klop was offering FMT as a therapy for autism.

"When it comes to unproven, unregulated and experimental things, we have to get something in place that protects autistic children and all disabled children from becoming, for lack of a better word, test subjects for their parents," Eaton said.

She wishes parents would spend less of their energy trying to cure their children's autism. She believes they're sending a harmful message there's something wrong with their kids that needs to be fixed.

"The best thing that they can do for their child is to support them, accept them instead of looking on the internet for some magical treatment," Eaton said.